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A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion (MountainTAP-29)

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com - Clinical.Trials@bms.com

NCT07063745
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Inclusion Criteria * Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease. * Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss. * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Participants must have at least 1 measurable lesion as per RECIST v1.1. Exclusion Criteria * Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy. * Participants must not have symptomatic brain metastases or spinal cord compression. * Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC). Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated. * Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing. * Other protocol-defined Inclusion/Exclusion criteria apply.
DRUG: BMS-986504, DRUG: Pembrolizumab, OTHER: Placebo, DRUG: Cisplatin, DRUG: Carboplatin, DRUG: Pemetrexed, DRUG: Paclitaxel, DRUG: Nab-paclitaxel
Metastatic Non-small Cell Lung Cancer With MTAP Deletion
PRMT5, Lung cancer, NSCLC, MTAP, CDKN2A, MRTX1719, First-line, Navlimetostat
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A. C. Camargo Cancer Center São Paulo, São Paulo
AO Santa Maria della Misericordia Perugia, Umbria
AOU della Campania Luigi Vanvitelli Naples, Campania
AZ Delta vzw Roeselare,
Adana Medical Park Seyhan Hastanesi Adana,
Alb Fils Kliniken GmbH Göppingen, Baden-Wurttemberg
Alexandra General Hospital of Athens Athens, Attikí
Antwerp University Hospital Edegem,
Apollo Hospitals Hyderabad,
Asan Medical Center Seoul,
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma Verona,
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano, Torino
Baptist Health Lexington Lexington, Kentucky
Bundeswehrkrankenhaus Ulm Ulm, Baden-Wurttemberg
CEDOES Vitória,
CENEIT Oncologicos Mexico City,
CHRU de Brest Brest, Finistère
CHU Bordeaux Haut-Leveque Pessac,
CHU Jean Minjoz Besançon, Doubs
CHU de Toulouse - Hopital Larrey Toulouse, Haute-garonne
Cancer Treamtent Clinic and Clinical Trials Sa de Cv Guadalajara, Jalisco
Centre Francois Baclesse Caen, Calvados
Centre Georges Francois Leclerc Dijon,
Centre Hospitalier Intercommunal de Creteil Créteil, Val-de-Marne
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois Vandœuvre-lès-Nancy,
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau Tours,
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman Liège,
Centre Hospitalier Universitaire de Nice - Hopital Pasteur Nice, Alpes-Maritimes
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes, Ille-et-vilaine
Centro Oncológico Korben Caba,
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul São Caetano do Sul, São Paulo
Centro de Pesquisa Sao Lucas Campinas,
Centrul de Diagnostic si Tratament Provita Bucharest,
Centrul de Oncologie "Sfântul Nectarie" Craiova,
Centrum Medyczne Pratia Poznan Poznan, Greater Poland Voivodeship
Centrum Onkologii im. Prof. Franciszka Lukaszczyka Bydgoszcz,
Chang Gung Medical Foundation-LinKou Branch Taoyuan,
Chi Mei Hospital - Liouying Branch Tainan,
Chu Gabriel Montpied Clermont-Ferrand, Puy-de-Dôme
Chulalongkorn University Bangkok,
Chungbuk National University Hospital Chungju,
Clinica de Oncologia Reichow Blumenau, Santa Catarina
Complex Oncology Center - Ruse EOOD Rousse,
Cro-Irccs Aviano, Pordenone
Dana-Farber Cancer Institute Boston, Massachusetts
Errikos Dunant Hospital Center Athens,
Faculty of Medicine Siriraj Hospital Bangkok, Bangkok
Fakultni nemocnice Hradec Kralove Hradec Králové,
Fakultni nemocnice Olomouc Olomouc,
Farkasgyepui Tudogyogyintezet Farkasgyepű,
Fondazione IRCCS Istituto Nazionale dei Tumori Milan,
Fred Hutchinson Cancer Center Seattle, Washington
Fujian Cancer Hospital Fuzhou, Fujian
Fundacion Estudios Clinicos Rosario, Santa Fe Province
Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto,
Fundação Pio XII - Hospital de Câncer de Barretos Barretos,
GenesisCare St Leonards St Leonards, New South Wales
Grampians Health Ballarat, Victoria
Groupe hospitalier Paris saint Joseph Paris, Île-de-France Region
Guangdong Provincial People's Hospital Guangzhou,
Guangxi Medical University Affiliated Cancer Hospital Nanning, Guangxi
H.R.U Málaga - Hospital General Málaga,
Hadassah Medical Center Jerusalem,
Harbin Medical University Cancer Hospital Ha’erbin,
Helios Clinical Research - Fort Lauderdale Fort Lauderdale, Florida
Highlands Oncology Group Springdale, Arkansas
Hokkaido University Hospital Hokkaido, Sapporo,
Hospices Civils de Lyon - Hopital Louis Pradel Bron,
Hospital Britanico de Buenos Aires Ciudad de Buenos Aires, Buenos Aires
Hospital General Universitario Gregorio Marañon Madrid,
Hospital Nossa Senhora da Conceicao Porto Alegre, Rio Grande do Sul
Hospital Universitari Vall d'Hebron Barcelona,
Hospital Universitario 12 de Octubre Madrid,
Hospital Universitario Puerta de Hierro Majadahonda Majadahonda,
Hospital Universitario Virgen del Rocio Seville,
Hubei Cancer Hospital Wuhan,
Hunan Cancer Hospital Changsha, Hunan
Huntsman Cancer Institute Salt Lake City, Utah
I.E.U. Medical Point Hastanesi Izmir, Karsiyaka, İzmir
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola Bologna,
Icesp - Instituto Do Câncer Do Estado de São Paulo São Paulo,
Institut Català d'Oncologia - L'Hospitalet Hospitalet, Barcelona [Barcelona]
Institut Curie Paris,
Institut Jean Godinot Reims,
Institut Paoli-Calmettes Marseille, Provence-Alpes-Côte d'Azur Region
Instituto Alexander Fleming Ciudad Autónoma de Buenos Aires, Buenos Aires
Instituto Nacional de Cancer - INCA Rio de Janeiro,
Instituto de Oncologia Saint Gallen Santa Cruz do Sul, Rio Grande do Sul
Institutul Oncologic Bucuresti "Prof. Dr. Alexandru Trestioreanu" Bucharest, Bucharest
Institutul Oncologic Cluj Cluj-Napoca,
Institutul Oncologic Cluj Cluj-Napoca,
Institutul Regional de Oncologie Iași,
Istituto di Candiolo - Fondazione del Piemonte per lOncologia Turin,
Kaiser Permanente Interstate Medical Office Central Portland, Oregon
Klinik Floridsdorf Vienna,
Klinik Löwenstein Löwenstein,
Krankenhaus Barmherzige Brüder Regensburg Regensburg, Bavaria
Landeskrankenhaus Rankweil Rankweil,
Leicester Royal Infirmary Leicester,
Liaoning Cancer Hospital Shenyang, Liaoning
Liga Norte Riograndense Contra O Cancer Natal, Rio Grande do Norte
Linyi Cancer Hospital Linyi,
Liv Hospital Ankara Ankara,
Local Institution - 0016 Afula, Northern District
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Local Institution - 0047 Zhengzhou, Henan
Local Institution - 0049 Beijing, Beijing Municipality
Local Institution - 0051 Jinan, Shandong
Local Institution - 0057 Changsha, Hunan
Local Institution - 0060 Chaïdári, Attikí
Local Institution - 0061 London, Kensington and Chelsea
Local Institution - 0068 Qingdao, Shandong
Local Institution - 0069 Bengaluru, Karnataka
Local Institution - 0072 Gurugram, Haryana
Local Institution - 0075 Changchun, Jilin
Local Institution - 0096 Drammen, Buskerud
Local Institution - 0104 Shenyang, Liaoning
Local Institution - 0107 Zhengzhou, Henan
Local Institution - 0108 Chongqing, Chongqing Municipality
Local Institution - 0119 Iași,
Local Institution - 0127 Scarborough, Maine
Local Institution - 0128 Rochester, New York
Local Institution - 0131 Fairfax, Virginia
Local Institution - 0163 Harderwijk, Gelderland
Local Institution - 0198 Hirakata, Osaka
Local Institution - 0215 Gauting,
Local Institution - 0220 Lublin, Lublin Voivodeship
Local Institution - 0225 Mexico City, Mexico City
Local Institution - 0230 Arnhem,
Local Institution - 0232 Sendai, Miyagi
Local Institution - 0234 Bunkyo-ku, Tokyo
Local Institution - 0235 Shimotsuga, Tochigi
Local Institution - 0237 Matsusaka, Mie-ken
Local Institution - 0238 Esslingen am Neckar, Baden-Wurttemberg
Local Institution - 0240 Hirakata, Osaka
Local Institution - 0241 Ulm,
Local Institution - 0242 Hamburg,
Local Institution - 0243 Nagoya, Aichi-ken
Local Institution - 0245 Hidaka, Saitama
Local Institution - 0247 Nanchang, Jiangxi
Local Institution - 0253 Barcelona, Catalunya [Cataluña]
Local Institution - 0255 Changsha, Hunan
Local Institution - 0257 Shenyang, Liaoning
Local Institution - 0259 Chongqing, Chongqing Municipality
Local Institution - 0261 Luoyang, Henan
Local Institution - 0263 Bangalore, Karnataka
Local Institution - 0264 Bangkok,
Local Institution - 0266 Songkhla,
Local Institution - 0267 Jingzhou, Hubei
Local Institution - 0270 Seoul, Seoul-teukbyeolsi [Seoul]
Local Institution - 0279 Nanjing, Jiangsu
Local Institution - 0281 Sulton, Surrey,
Local Institution - 0283 Taiyuan, Shanxi
Local Institution - 0284 Shenyang, Liaoning
Local Institution - 0286 Poznan, Greater Poland Voivodeship
Local Institution - 0288 Budapest,
Local Institution - 0290 Gyula, Bekes County
Local Institution - 0291 Gyöngyös, Heves County
Local Institution - 0294 Mexico City, Mexico City
Local Institution - 0297 Oaxaca City, Oaxaca
Local Institution - 0298 Monterrey, Nuevo León
Local Institution - 0305 Bogotá, Cundinamarca
Local Institution - 0306 Montería, Departamento de Córdoba
Local Institution - 0315 Panagyurishte, Pazardzhik
Local Institution - 0317 Adana,
Local Institution - 0319 Edirne,
Local Institution - 0323 Shatin,
Local Institution - 0326 Guadalajara, Jalisco
Local Institution - 0327 Chihuahua City,
Local Institution - 0328 Querétaro,
Local Institution - 0330 Medellín, Antioquia
Local Institution - 0331 Puebla City,
Local Institution - 0334 Otashi, Gunma
Local Institution - 0335 Shiwa-gun Yahaba-cho, Iwate
Local Institution - 0336 Himeji, Hyōgo
Local Institution - 0344 Bengaluru, Karnataka
Local Institution - 0345 Mumbai, Maharashtra
Local Institution - 0350 Antalya,
Local Institution - 0352 Nanjing, Jiangsu
Local Institution - 0353 Shijiazhuang, Hebei
Local Institution - 0368 Garran,
Local Institution - 0374 El Paso, Texas
Local Institution - 0377 The Woodlands, Texas
Local Institution - 0387 Changsha, Hunan
Local Institution - 0405 Detroit, Michigan
Local Institution - 0408 Guiyang, Guizhou
Local Institution - 0418 Ann Arbor, Michigan
Local Institution - 0420 Traverse City, Michigan
Local Institution - 0430 St. Petersburg, Florida
Local Institution - 0432 Liverpool, New South Wales
Local Institution - 0433 Dallas, Texas
Local Institution - 0444 Los Angeles, California
Local Institution - 0445 Veldhoven, North Brabant
Local Institution - 0467 Lebanon, New Hampshire
Local Institution - 0472 Buenos Aires,
Local Institution - 0473 Providencia, Santiago Metropolitan
Local Institution - 0475 Santiago,
Local Institution - 0476 Recoleta, Santiago Metropolitan
Local Institution - 0477 Río Cuarto, Córdoba Province
Local Institution - 0480 Madrid,
Local Institution - 0481 Thessaloniki,
Local Institution - 0483 Rome,
Local Institution - 0486 Siena, Tuscany
Local Institution - 0497 Los Alamitos, California
Local Institution - 0514 Winston-Salem, North Carolina
Local Institution - 0515 Knoxville, Tennessee
Local Institution - 0518 Schenectady, New York
Local Institution - 0523 Tampa, Florida
Local Institution - 0551 Bonn, North Rhine-Westphalia
Local Institution - 0559 Hershey, Pennsylvania
Local Institution - 0566 Antofagasta,
Local Institution - 0568 Lujan de Cuyo, Mendoza Province
Local Institution - 0571 Suwon, Kyǒnggi-do
Local Institution - 0573 Seoul, Seoul-teukbyeolsi [Seoul]
Local Institution - 0574 Heerlen, Limburg
Local Institution - 0580 Tübingen, Baden-Wurttemberg
Local Institution - 0582 Hemer, North Rhine-Westphalia
Local Institution - 0585 Marousi, North Athens
Local Institution - 0593 Ankara,
Local Institution - 0594 Warsaw, Masovian Voivodeship
Local Institution - 0595 Istanbul,
Local Institution - 0599 Villejuif, Val-De-Marne
Local Institution - 0600 Manchester, New Hampshire
Local Institution - 0603 Oslo,
Local Institution - 0604 Elverum, Innlandet
Local Institution - 0605 Decatur, Illinois
Local Institution - 0606 Newark, Delaware
Local Institution - 0607 Oradea, Bihor County
Local Institution - 0608 Greenville, South Carolina
Local Institution - 0609 Mexico City, Mexico City
Local Institution - 0612 Jelenia Góra, Lower Silesian Voivodeship
Local Institution - 0614 Ostrava, Ostrava Město
Local Institution - 0615 Zapopan, Jalisco
Local Institution - 0617 Donauwörth, Bavaria
Local Institution - 0618 Rosario, Santa Fe Province
Local Institution - 0619 Cluj-Napoca, Cluj
Local Institution - 0620 Nashik, Maharashtra
Local Institution - 0621 Beijing, Beijing Municipality
Local Institution - 0623 Traunstein, Bavaria
Local Institution - 0626 Essen, North Rhine-Westphalia
Local Institution - 0627 Lujan de Cuyo, Mendoza Province
Local Institution - 0628 Puebla City,
Local Institution - 0629 Tijuana, Estado de Baja California
LungenClinic Grosshansdorf Großhansdorf, Schleswig-Holstein
Lungenfachklinik Immenhausen Immenhausen,
Lyell McEwin Hospital Elizabeth Vale, South Australia
Mayo Clinic in Arizona - Phoenix Phoenix, Arizona
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester, Minnesota Rochester, Minnesota
Mazowiecki Szpital Onkologiczny Wieliszew, Masovian Voivodeship
Meir Medical Center Kfar Saba,
NAIC - Instituto do Cancer Bauru, São Paulo
Nanjing First Hospital Nanjing,
National Cancer Center Goyang-si, Gyeonggi-do
National Cancer Center Hospital East Kashiwa, Chiba
National Cheng Kung University Hospital Tainan,
National Hospital Organization Kyushu Cancer Center Fukuoka,
National Hospital Organization Okayama Medical Center Okayama,
National Taiwan University Hospital Taipei,
Oncology Hematology West P.C. dba Nebraska Cancer Specialists Omaha, Nebraska
Ordensklinikum Linz GmbH Elisabethinen LINZ CET,
Osaka City General Hospital Osaka,
Ospedale San Raffaele Milan,
Ospedale Santa Maria delle Croci Ravenna, Emilia-Romagna
Peking University People's Hospital Beijing,
Pius Hospital Oldenburg Oldenburg, Lower Saxony
Princess Alexandra Hospital Woolloongabba, Queensland
Pronutrir Fortaleza,
Providence Portland Medical Center Portland, Oregon
Queen Mary Hospital Hong Kong,
Radiology Therapeutic Center Otopeni, Ilfov
Rambam Health Care Campus Haifa,
Rigshospitalet University Hospital Copenhagen,
Robert Bosch Krankenhaus GmbH Stuttgart,
Royal Hobart Hospital Hobart, Tasmania
S.C. Centrul de Oncologie Euroclinic S.R.L. Iași,
SC Radiotherapy Center Cluj SRL Florești, Cluj
Sahlgrenska Universitetssjukhuset Gothenburg, Västra Götalands LÄN [se-14]
Samsung Medical Center Seoul,
Sarah Cannon Research Institute UK London, London, CITY of
Sarawak General Hospital Kuching,
Seoul National University Bundang Hospital Seongnam-si,
Seoul St.Mary'S Hospital, The Catholic University Of Korea Seoul,
Severance Hospital, Yonsei University Health System Seoul,
Shanghai Chest Hospital Shanghai,
Sheba Medical Center Ramat Gan,
Sichuan Cancer Hospital Chengdu,
Specialized Hospital for Active Treatment of Oncology - Haskovo Haskovo,
Spitalul Municipal Schuller Ploiești Ploieşti,
St. Luke's Cancer Institute: Boise Boise, Idaho
Sunshine Coast University Hospital Birtinya, Queensland
Szpital Specjalistyczny w Prabutach Spolka z o.o. Prabuty, Pomeranian Voivodeship
TUM Klinikum München, Bavaria
Taipei Medical University Hospital Taipei,
The First Affiliated Hospital of Xiamen University Xiamen,
The First Affiliated Hospital, Sun Yat-sen University Guangzhou, Guangdong
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou, Zhejiang
The First affiliated hospital of Nanchang University (Xianghu campus) Nanchang,
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Columbus, Ohio
Theagenio Hospital Thessaloniki, Kentrikí Makedonía
Thoracic General Hospital of Athens "I Sotiria" Athens, Attikí
Trakia Hospital Stara Zagora,
USC/Norris Comprehensive Cancer Center Los Angeles, California
UZ Brussel Brussels, Brussels Capital
Uludag Universitesi Bursa,
Unimed Porto Alegre Porto Alegre, Rio Grande Do Sil
University General Hospital of Larissa Larissa,
University Hospital of Patras Pátrai,
University Malaya Medical Centre Kuala Lumpur,
University Medical Center Groningen Groningen,
University Multidisciplinary Hospital for Active Treatment "St. Ekaterina" Sofia,
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EAD Sofia,
University of Arizona Cancer Center Tucson, Arizona
University of Kentucky Chandler Medical Center Lexington, Kentucky
University of Texas MD Anderson Cancer Center Houston, Texas
Virginia Commonwealth University Richmond, Virginia
WMCHealth Advanced Physician Services Hawthorne, New York
West China Hospital Sichuan University Chengdu, Sichuan
Wuhan Union Hospital Cancer Center Wuhan, Hubei
Zhejiang Cancer Hospital Hangzhou,
Zhongshan Hospital,Fudan University Shanghai,

Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies (CRETE)

E. Vincent Faustino, MD, MHS - vince.faustino@yale.edu

NCT04924322
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Inclusion criteria
• \>36 weeks corrected gestational to \<17 years old
• \<24 hours after insertion of an untunneled CVC
• CVC inserted in the internal jugular or femoral vein Exclusion criteria
• Radiologic diagnosis of CADVT in the site of insertion in prior 6 weeks
• Currently receiving an antithrombotic agent, e.g., LMWH, UFH, warfarin and aspirin, but not UFH at dose to maintain patency of a vascular catheter
• Presence of clinically relevant bleeding, i.e., hemoglobin decreased ≥2 g/dl in 24 hours, required medical or surgical intervention to restore hemostasis, or in the retroperitoneum, pulmonary, intracranial or central nervous system, in the prior 60 days
• Surgery in the prior 7 days
• Major trauma in the prior 7 days
• Presence of coagulopathy, i.e., INR \>2.0, aPTT \>50 seconds or platelet count \<50 x 10\^3/mcL
• Presence of renal failure, i.e., creatinine clearance \<30 mL/min/1.73 m2
• Known hypersensitivity to heparin or pork products
• Laboratory confirmed HIT
• Current pregnancy or lactation
• Presence of an epidural catheter
• Limitation of care
• Previous enrollment in the CRETE Studies
DRUG: Enoxaparin
Deep Venous Thrombosis
child, critical illness, venous thromboembolism, enoxaparin, thrombin generation, bleed
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Study Locations

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Location Contacts
Arkansas Children's Hospital Little Rock, Arkansas Masson Spriggs - (SpriggsMK@archildrens.org)
Children's Hospital Colorado Aurora, Colorado Rachel Greer - (Rachel.Greer@childrenscolorado.org)
Children's Hospital St. Louis St Louis, Missouri Jessica Archie-Dilworth - (j.archie-dilworth@wustl.edu)
Children's Hospital Wisconsin Milwaukee, Wisconsin Sadaf Shad, MD - (sshad@mcw.edu)
Children's Hospital of Illinois at OSF Saint Francis Medical Center Peoria, Illinois Carleen Chaput - (Carleen.M.Chaput@osfhealthcare.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Alanah McKelvey - (mckelveya@chop.edu)
Children's Hospital of Richmond Richmond, Virginia
Children's Of Alabama Birmingham, Alabama Meghan Murdock, RN - (Mmdmurdock@uabmc.edu)
Dell Children's Medical Canter Austin, Texas Michael Box - (michael.box@ascension-external.org)
Golisano Children's Hospital Fort Myers, Florida Eileen Taillie - (Eileen_Taillie@URMC.Rochester.edu)
Hassenfeld Children's Hospital New York, New York Sandra Deygoo - (nagamah.deygoo@nyulangone.org)
Johns Hopkins All Children's St. Petersburg, Florida Lexi Dallas - (adallas2@jhmi.edu)
Maria Fareri Children's Hospital Valhalla, New York Sere Politano - (Sere.Politano@wmchealth.org)
Nationwide Children's Hospital Columbus, Ohio
New York Presbyterian Hospital New York, New York Oleksiy Svezhenets, MD - (ols4009@med.cornell.edu)
Penn State Hershey Children's Hospital Hershey, Pennsylvania Debbie Spear, RN - (dspear@pennstatehealth.psu.edu)
Stead Family Children's Hospital Iowa City, Iowa Maureen Austin, RN, MPH, BSN - (Maureen-Austin@uiowa.edu)
UH Rainbow Babies & Children's Hospital Cleveland, Ohio Raj Rasal - (rajashri.rasal@uhhospitals.org) SaTia Sinclair - (satia.sinclair@uhhospitals.org)
UTSW Medical Center; Children's Medical Center of Dallas Dallas, Texas Teddy Muisyo, MD - (Teddy.Muisyo@UTSouthwestern.edu) Selby Chu, MD - (Selby.Chu@UTSouthwestern.edu)
University of Florida -UF Health Gainesville, Florida Melissa Lingus - (Melissa.Lingis@peds.ufl.edu)
University of Oklahoma Oklahoma City, Oklahoma Tracy Jones - (Tracy-Jones@ouhsc.edu)
Yale-New Haven Children's Hospital New Haven, Connecticut Michelle Ecarma - (michelle.ecarma@yale.edu)

A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

ctrrecruit@vcu.edu

NCT04546399
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Inclusion Criteria:
* Patients must be \>= 1 and \< 31 years at time of enrollment * Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories: * Isolated bone marrow relapse * Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse * Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes * Patients with Down syndrome (DS) are eligible in the following categories: * Isolated bone marrow relapse * Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age * Of note, for patients with developmental delay (e.g., Down syndrome) regardless of age, Lansky scale may be substituted for Karnofsky scale. However, the requirement for ECOG 0-2 remains, regardless of known history of developmental delay * Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study * Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19 expression * Patients must not have had a prior hematopoietic stem cell transplant * A single intrathecal chemotherapy at the time of relapse will be allowed. If \< 7 days have elapsed between this intrathecal therapy (IT) and the start of protocol therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine, or triple intrathecal) may be omitted * In the 28 days prior to enrollment, up to five days of post-relapse, pre-enrollment therapy (steroids and/or hydroxyurea only) is permissible * Patients with Down syndrome who received pre-enrollment therapy and have a white blood count (WBC) \>= 30,000/ul at the time of enrollment still must receive protocol specified cytoreductive therapy with vincristine and dexamethasone, and no "washout" is required * Patients with Down syndrome who received pre-enrollment therapy and have a WBC \< 30,000/ul at the time of enrollment must be given a 24 hour "washout" before starting immunotherapy * Note: There is no waiting period or "washout" for patients who relapse while receiving upfront therapy * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/sex as follows (within 7 calendar days prior to enrollment): * Age: Maximum serum creatinine (mg/dL) * 1 to \< 2 years: 0.6 (male), 0.6 (female) * 2 to \< 6 years: 0.8 (male), 0.8 (female) * 6 to \< 10 years: 1 (male), 1 (female) * 10 to \< 13 years: 1.2 (male), 1.2 (female) * 13 to \< 16 years: 1.5 (male), 1.4 (female) * \>= 16 years: 1.7 (male), 1.4 (female) * The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Center for Disease Control (CDC) * Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \>= 50% by echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram * No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Patients with B-lymphoblastic lymphoma (B-LLy) * Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia * Patients with Philadelphia chromosome positive (Ph+) B-ALL or ABL class Ph-like B-ALL (i.e. rearrangements involving ABL1, ABL2, CSF1R or PDGFRB and predicted to be sensitive to imatinib or dasatinib) * Patients with mixed phenotype acute leukemia (MPAL) * Patients with known Charcot-Marie-Tooth disease * Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype * Patients with active, uncontrolled infection defined as: * Positive bacterial blood culture within 48 hours of study enrollment * Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection if cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline. * Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed if blood cultures are negative for \> 48 hours * A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection * Active viral or protozoal infection requiring IV treatment * Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible. * Patients with uncontrolled HIV, hepatitis B, or hepatitis C infection. Of note, patients with known human immunodeficiency virus (HIV) infection on effective anti-retroviral therapy with undetectable viral load for at least the last 6 months prior to enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who have been treated and have no viral detectable burden are also eligible * Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with CNS involvement * Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible Patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved * Patients with an active known/suspected autoimmune disease are not eligible. However, patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll * Patients with DS patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are not eligible * Note: Group 3 and 4 patients with known non-hematopoietic, non-CNS/testicular extramedullary disease (i.e., chloromatous disease) are eligible if this is NOT the only site of relapsed disease * Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment. Patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of this study. Men with female partners of childbearing potential should use effective contraception during the duration of their treatment. The effect of blinatumomab on fertility has not been evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing potential (WOCBP) not using contraception. Females of reproductive potential must use effective contraception during treatment and for at least 48 hours after the last dose of blinatumomab. Studies in animal models have shown that nivolumab can adversely impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy. WOCBP receiving nivolumab must continue contraception for a period of at least 5 months after the last dose of nivolumab. It is unknown whether nivolumab is present in breast milk, thus breastfeeding should be discontinued while a patient is receiving nivolumab * Lactating females are not eligible unless they agree to not breastfeed their infants. It is unknown whether blinatumomab or its metabolites are excreted in human breast milk. Women are not permitted to breastfeed while receiving blinatumomab and for the last 48 hours after the last blinatumomab dose. Due to the potential for serious adverse reactions in the breastfed infant, women are not permitted to breastfeed during treatment and for 5 months after the last nivolumab dose
RADIATION: 3-Dimensional Conformal Radiation Therapy, DRUG: Asparaginase Erwinia chrysanthemi, PROCEDURE: Biospecimen Collection, BIOLOGICAL: Blinatumomab, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Calaspargase Pegol, DRUG: Cytarabine, DRUG: Dexamethasone, DRUG: Hydrocortisone Sodium Succinate, PROCEDURE: Lumbar Puncture, DRUG: Mercaptopurine, DRUG: Methotrexate, BIOLOGICAL: Nivolumab, DRUG: Pegaspargase, DRUG: Vincristine Sulfate
Down Syndrome, Recurrent B Acute Lymphoblastic Leukemia
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Show 227 locations

Study Locations

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Location Contacts
AdventHealth Orlando Orlando, Florida Site Public Contact - (FH.Cancer.Research@flhosp.org)
Albany Medical Center Albany, New York
Alberta Children's Hospital Calgary, Alberta
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Ann M Wierman MD LTD Las Vegas, Nevada
Arkansas Children's Hospital Little Rock, Arkansas
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (Jennifer.spinelli@orlandohealth.com)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Banner Children's at Desert Mesa, Arizona
Banner University Medical Center - Tucson Tucson, Arizona Site Public Contact - (UACC-IIT@uacc.arizona.edu)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Beacon Kalamazoo Kalamazoo, Michigan
Blank Children's Hospital Des Moines, Iowa Site Public Contact - (samantha.mallory@unitypoint.org)
British Columbia Children's Hospital Vancouver, British Columbia
Bronson Battle Creek Battle Creek, Michigan
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
C S Mott Children's Hospital Ann Arbor, Michigan
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec,
Camden Clark Medical Center Parkersburg, West Virginia
Cancer Care Specialists - Reno Reno, Nevada
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan
CancerCare Manitoba Winnipeg, Manitoba
Cardinal Glennon Children's Medical Center St Louis, Missouri
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Carson Tahoe Regional Medical Center Carson City, Nevada
Cedars-Sinai Medical Center Los Angeles, California Site Public Contact - (Cancer.trial.info@cshs.org)
Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
Children's Hospital Colorado Aurora, Colorado Site Public Contact - (josh.b.gordon@nsmtp.kp.org)
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital Medical Center Of Akron Akron, Ohio
Children's Hospital New Orleans New Orleans, Louisiana
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (oncologyresearch@peds.uab.edu)
Children's Hospital of Michigan Detroit, Michigan
Children's Hospital of Orange County Orange, California Site Public Contact - (oncresearch@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Site Public Contact - (CancerTrials@email.chop.edu)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (jean.tersak@chp.edu)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (bridget.medina@christushealth.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin Site Public Contact - (MACCCTO@mcw.edu)
Children's Hospital of the King's Daughters Norfolk, Virginia Site Public Contact - (CCBDCresearch@chkd.org)
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota Site Public Contact - (pauline.mitby@childrensmn.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (COGResearchGroup@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
City of Hope Comprehensive Cancer Center Duarte, California
Cleveland Clinic Foundation Cleveland, Ohio
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada
Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada
Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada
Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada
Comprehensive Cancer Centers of Nevada - Town Center Las Vegas, Nevada
Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson, Nevada
Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson, Nevada
Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada
Connecticut Children's Medical Center Hartford, Connecticut
Cook Children's Medical Center Fort Worth, Texas Site Public Contact - (CookChildrensResearch@cookchildrens.org)
Corewell Health Beaumont Troy Hospital Troy, Michigan
Corewell Health Children's Royal Oak, Michigan
Corewell Health Dearborn Hospital Dearborn, Michigan
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan
Corewell Health Reed City Hospital Reed City, Michigan
Corewell Health William Beaumont University Hospital Royal Oak, Michigan
Covenant Children's Hospital Lubbock, Texas Site Public Contact - (mbisbee@providence.org)
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Children's Hospital Dayton, Ohio
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
Driscoll Children's Hospital Corpus Christi, Texas Site Public Contact - (Crystal.DeLosSantos@dchstx.org)
Duke University Medical Center Durham, North Carolina
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
East Tennessee Childrens Hospital Knoxville, Tennessee
Eastern Maine Medical Center Bangor, Maine
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
Hackensack University Medical Center Hackensack, New Jersey
Hope Cancer Care of Nevada Las Vegas, Nevada
Hope Cancer Care of Nevada-Pahrump Pahrump, Nevada
IWK Health Centre Halifax, Nova Scotia
Inova Fairfax Hospital Falls Church, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Janeway Child Health Centre St. John's, Newfoundland and Labrador Site Public Contact - (beverlyj.mitchell@easternhealth.ca)
John Hunter Children's Hospital Hunter Regional Mail Centre, New South Wales
Johns Hopkins All Children's Hospital St. Petersburg, Florida Site Public Contact - (Ashley.Repp@jhmi.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente Downey Medical Center Downey, California
Kaiser Permanente Los Angeles Medical Center Los Angeles, California
Kaiser Permanente-Anaheim Anaheim, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Bellflower Bellflower, California
Kaiser Permanente-Fontana Fontana, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Diego Zion San Diego, California Site Public Contact - (clinical.trials@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Kingman Regional Medical Center Kingman, Arizona
Las Vegas Cancer Center-Henderson Henderson, Nevada
Las Vegas Cancer Center-Medical Center Las Vegas, Nevada
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York
Legacy Emanuel Children's Hospital Portland, Oregon
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Loma Linda University Medical Center Loma Linda, California
Loyola University Medical Center Maywood, Illinois
Lucile Packard Children's Hospital Stanford University Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California
Lurie Children's Hospital-Chicago Chicago, Illinois
Madigan Army Medical Center Tacoma, Washington Site Public Contact - (melissa.a.forouhar.mil@health.mil)
Maimonides Medical Center Brooklyn, New York
Maine Children's Cancer Program Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Mattel Children's Hospital UCLA Los Angeles, California
Medical City Dallas Hospital Dallas, Texas
Memorial Health University Medical Center Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida Site Public Contact - (OHR@mhs.net)
Memorial Sloan Kettering Cancer Center New York, New York
Mercy Hospital Saint Louis St Louis, Missouri
Methodist Children's Hospital of South Texas San Antonio, Texas Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com)
Michigan State University East Lansing, Michigan
Miller Children's and Women's Hospital Long Beach Long Beach, California
Mission Hospital Asheville, North Carolina Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Morristown Medical Center Morristown, New Jersey
Munson Medical Center Traverse City, Michigan
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
NYP/Weill Cornell Medical Center New York, New York
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Nemours Children's Clinic - Pensacola Pensacola, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (Allison.bruce@nemours.org)
Nemours Children's Hospital Orlando, Florida Site Public Contact - (Allison.bruce@nemours.org)
Newark Beth Israel Medical Center Newark, New Jersey Site Public Contact - (Christine.Kosmides@rwjbh.org)
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington
Norton Children's Hospital Louisville, Kentucky Site Public Contact - (CancerResource@nortonhealthcare.org)
OSF Children's Hospital of Illinois Peoria, Illinois Site Public Contact - (ChildrensHospitalofIllinois@osfhealthcare.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana
OptumCare Cancer Care at Charleston Las Vegas, Nevada
OptumCare Cancer Care at Fort Apache Las Vegas, Nevada
OptumCare Cancer Care at MountainView Las Vegas, Nevada
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Overlake Medical Center Bellevue, Washington
PCR Oncology Arroyo Grande, California
Penn State Children's Hospital Hershey, Pennsylvania
Perth Children's Hospital Perth, Western Australia
Phoenix Childrens Hospital Phoenix, Arizona
Presbyterian Hospital Albuquerque, New Mexico Site Public Contact - (wburman@phs.org)
Primary Children's Hospital Salt Lake City, Utah
Prisma Health Cancer Institute - Eastside Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Richland Hospital Columbia, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
ProMedica Flower Hospital Sylvania, Ohio
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Alaska Medical Center Anchorage, Alaska
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington Site Public Contact - (HopeBeginsHere@providence.org)
Queensland Children's Hospital South Brisbane, Queensland
Rady Children's Hospital - San Diego San Diego, California
Rainbow Babies and Childrens Hospital Cleveland, Ohio
Renown Regional Medical Center Reno, Nevada Site Public Contact - (Renown-CRD@renown.org)
Rhode Island Hospital Providence, Rhode Island
Riley Hospital for Children Indianapolis, Indiana
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com)
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey
Sacred Heart Hospital Pensacola, Florida
Saint Christopher's Hospital for Children Philadelphia, Pennsylvania
Saint Francis Children's Hospital Tulsa, Oklahoma
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida Site Public Contact - (jennifer.manns@baycare.org)
Saint Joseph's Regional Medical Center Paterson, New Jersey Site Public Contact - (HallL@sjhmc.org)
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Mary's Medical Center West Palm Beach, Florida
Saint Mary's Regional Medical Center Reno, Nevada
Saint Peter's University Hospital New Brunswick, New Jersey Site Public Contact - (kcovert@saintpetersuh.com)
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Seattle Children's Hospital Seattle, Washington
Sinai Hospital of Baltimore Baltimore, Maryland
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
Summerlin Hospital Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Sunrise Hospital and Medical Center Las Vegas, Nevada
Sutter Medical Center Sacramento Sacramento, California Site Public Contact - (clinicalresearch@sutterhealth.org)
Sydney Children's Hospital Randwick, New South Wales
Tampa General Hospital Tampa, Florida Site Public Contact - (syapchanyk@tgh.org)
The Children's Hospital at TriStar Centennial Nashville, Tennessee
The Children's Hospital at Westmead Westmead, New South Wales
The Montreal Children's Hospital of the MUHC Montreal, Quebec
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York
Trinity Health Grand Rapids Hospital Grand Rapids, Michigan
Trinity Health Muskegon Hospital Muskegon, Michigan
Tufts Children's Hospital Boston, Massachusetts
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.edu)
UF Health Cancer Institute - Gainesville Gainesville, Florida
UMC Cancer Center / UMC Health System Lubbock, Texas
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
USA Health Strada Patient Care Center Mobile, Alabama
UT MD Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
United Hospital Center Bridgeport, West Virginia
University Pediatric Hospital San Juan,
University of Alberta Hospital Edmonton, Alberta
University of California Davis Comprehensive Cancer Center Sacramento, California
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Illinois Chicago, Illinois
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Michigan Health - West Wyoming, Michigan
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Rochester Rochester, New York
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Vermont and State Agricultural College Burlington, Vermont Site Public Contact - (rpo@uvm.edu)
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Children's Hospital Madera, California Site Public Contact - (Research@valleychildrens.org)
Valley Medical Center Renton, Washington
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
WVUH-Berkely Medical Center Martinsburg, West Virginia
Wake Forest University Health Sciences Winston-Salem, North Carolina
Walter Reed National Military Medical Center Bethesda, Maryland
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
West Michigan Cancer Center Kalamazoo, Michigan
West Virginia University Charleston Division Charleston, West Virginia
West Virginia University Healthcare Morgantown, West Virginia Site Public Contact - (cancertrialsinfo@hsc.wvu.edu)

A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE) (EMPIRE)

Department of Site and Study Management (DSSM) - industry.trials@nsabp.org

NCT07058012
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Inclusion Criteria:
* The patient must have consented to participate and, prior to beginning specific study procedures, must have signed and dated appropriate Institutional Review Board (IRB) -approved consent forms that conform to federal and institutional guidelines for study treatment. * Patients must be greater than or equal to18 years old. * The ECOG performance status must be 0-1. * Patients must have confirmed histologic and pathologic stage II/III colon, stage II/III rectal, or oligometastatic stage IV colorectal adenocarcinoma (per AJCC 8th edition). * There must be documentation by CT scan with contrast that the patient has no definitive evidence of (non-resected or non-ablated) metastatic disease including assessment of chest, abdomen, and pelvis at the time of study enrollment * All patients must have had a complete (R0) resection of their primary tumor and resected or ablated (radiofrequency ablation, stereotactic body radiation therapy \[SBRT\], microwave ablation, etc.\]) oligometastatic disease if present AND at least 3 months of a standard systemic chemotherapy regimen (e.g., FOLFOX or CAPOX or fluoropyrimidine monotherapy). This includes either adjuvant chemotherapy for colon cancer or perioperative (adjuvant or neoadjuvant) chemotherapy for rectal cancer or oligometastatic colon or rectal cancer. Chemoradiotherapy for rectal cancer (as a component of curative treatment) is acceptable. NOTE: Patients who achieve a clinical complete response and opt for a non-operative approach to their primary tumor management are not eligible. * Patients must be ctDNA-positive by an assay run in any CLIA-certified lab obtained within 2 weeks to 12 months following completion of definitive all curative therapy for colorectal cancer. * Tumor status of microsatellite stability (MSS) or Proficient mismatch repair (pMMR) is confirmed through a standard of care assay through a CLIA-certified lab. * At the time of study entry, blood counts performed within 28 days prior to study entry must meet the following criteria: * ANC must be greater than or equal to (≥) 1000/mm3, * Platelet count must be ≥ to 80,000/mm3; and * Hemoglobin must be ≥ 8 g/dL. (Note: transfusions may be used to correct hemoglobin for patients experiencing anemia from therapy who otherwise would be eligible for the study.) * Albumin greater than (\>) 3.0 g/dL. * The following criteria for evidence of adequate hepatic function performed within 28 days prior to study entry must be met: * Total bilirubin less than or equal to (≤) 1.5 x ULN * AST and ALT must be ≤ 3.0 x ULN for the lab. (Note: In patients with elevated ALT or AST, the values must be stable for at least 2 weeks and with no evidence of biliary obstruction on imaging.) * Creatinine must be ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 40mL/min. * All prior chemotherapy toxicities (excluding alopecia, amenorrhea, and peripheral neuropathy) must be less than (\<) Grade 2 at the time study therapy is to begin unless AE(s) are clinically stable on supportive therapy. * Patients must have no evidence of opportunistic infections. * Patients of childbearing potential must have a negative pregnancy per institutional policies prior to receiving the first dose of study therapy. * Male and female patients with reproductive potential must agree to use accepted effective methods of contraception while receiving study therapy and for at least 180 days (6 months) after the completion of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
Exclusion Criteria:
* Colon cancer other than adenocarcinoma, e.g., sarcoma, lymphoma, carcinoid. * Patients with MSI-high (dMMR) tumors. * Use and/or receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, monoclonal anti-bodies) or radiation therapy within 4 weeks prior to receiving first dose of study therapy or associated with immune-mediated adverse events (imAEs) that were Grade ≥1 within 90 days prior to the first dose of study therapy or associated with toxicity that resulted in discontinuation of the immune-modulating agent. * History of active or latent tuberculosis (TB) infection. If the presence of TB (active or latent) is established, then treatment for TB must be completed according to local guidelines prior to the screening. * Active untreated or uncontrolled systemic fungal, bacterial, or viral infections, or active infection requiring systemic anti-infectious therapy. * Current or history of systemic autoimmune disease requiring systemic immunosuppressive therapy will not be allowed. Note: the following will not be exclusionary: 1) the presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody titer or lupus anticoagulant) without associated symptoms; 2) clinical evidence of vitiligo or other forms of depigmenting illness; 3) mild autoimmunity not impacting the function of major organs (e.g., controlled Hashimoto thyroiditis, limited psoriasis), Type I diabetes. * Patients will be excluded if they are on systemic steroid therapy that cannot be discontinued (except for the use of prednisone or equivalent \<0.125mg/kg/day as replacement therapy). Inhaled or topical steroids are permitted. * Receipt of live attenuated vaccination within 30 days prior to study entry. * Known active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCB) infections. Note: Patients with a history of hepatitis C virus (HCV) infection must have been treated and with confirmation of cure, can be eligible. * History of allogeneic organ or bone marrow transplantation. * Any of the following cardiovascular conditions: * Documented NYHA Class II, III or IV congestive heart failure, * History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to starting study treatment * Transient ischemic attack (TIA) or stroke within 1 year. * History of myocarditis * Troponin T (TnT) or troponin I (TnI) \> 2x institutional ULN at baseline. Patients with TnT or TnI levels between \> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are \> 1 to 2x ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on medical judgement in the patient's best interest. * Active, documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis). * Major surgical procedure within 28 days prior to study entry. * Other malignancies: unless the patient is considered disease-free and has completed therapy for the malignancy greater than or equal to 36 months prior to study entry. Patients with the following cancers are eligible if diagnosed and definitively treated within the past 12 months: carcinoma in situ of the cervix, and basal cell and squamous cell carcinoma of the skin. Other in situ neoplasms will be reviewed by the Protocol Officer and/or Protocol Chair. * Psychiatric or addictive disorders or other conditions that in the opinion of the investigator would preclude the patient from meeting the study requirements or interfering with interpretation of study results. * Pregnancy or lactation at the time of study entry. * Use of any investigational agent within 28 days prior to the first dose of study therapy.
DRUG: Cemiplimab, DRUG: cemiplimab plus fianlimab, DRUG: cemiplimab + REGN7075, OTHER: ctDNA testing
Colo-rectal Cancer
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Study Locations

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Allegheny General Hospital Pittsburgh, Pennsylvania
Ballad Health Cancer Center - Kingsport Kingsport, Tennessee
Bon Secours St. Francis Medical Center Midlothian, Virginia
First Health of the Carolinas Pinehurst, North Carolina
Huntsman Cancer Institute - University of Utah Salt Lake City, Utah
Magee-Womens Hospital of UPMC Pittsburgh, Pennsylvania
Missouri Baptist St Louis, Missouri
University of Florida Gainesville, Florida
University of Iowa - Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kansas Cancer Center Kansas City, Kansas
University of Maryland Greenbaum Baltimore, Maryland
University of Virginia Health Charlottesville, Virginia
Virginia Commonwealth University - Massey Richmond, Virginia

Cryoablation for Monomorphic Ventricular Tachycardia (VTS) (FULCRUM-VT)

Nabil Jubran, MS - njubran@adagiomedical.com

NCT07650032
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Inclusion Criteria:
* IC 1 Male or female ≥ 18 years * IC 2 Patients with a clinical indication for catheter ablation due to ischemic and/or non-ischemic heart disease and recurrent symptomatic sustained scar-mediated monomorphic Ventricular Tachycardia. * IC 3 Any of the following: * Ischemic cardiomyopapthy (ICM) patients with prior history of myocardial infarction with Q waves, focal wall motion abnormality on imaging, fixed perfusion defect correlating with coronary stenosis or prior coronary intervention, 20% ≤ LVEF \< 50%. * non-ischemic cardiomyopathy (NICM) patients with scar in a territory without coronary stenosis as evidenced by CMR imaging within the prior 90 days or intra-procedurally using EAM and PES prior to investigational device use, 20% ≤ LVEF \< 50% * Arrhythmogenic right ventricular cardiomyopathy (ARVC) * IC 4 Has received a market-released ICD prior to enrollment * IC 5 Patient has had at least 1 documented spontaneous episode of SMVT within the previous 6 months * IC 6 Refractory to, or intolerant of, at least one Class III AAD. (Refractory or intolerant defined as AAD failure due to recurrent VT, not tolerated/ desired due to side effects) * IC 7 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study * IC 8 Willingness and ability to give an informed consent
Exclusion Criteria:
* EC 1 Intracardiac thrombus by TTE or TEE within 48 hours prior to the procedure * EC 2 Presence of isolated epicardial scar(s) requiring epicardial ablation identified by either preoperative CMR imaging within 90 days of procedure or intra-procedurally using EAM and PES prior to investigational device use * EC 3 VTs due to any of the following causes:
• Idiopathic VT
• Automaticity or triggered activity
• Bundle Branch Reentry (BBR)
• Any focal tachycardia (e.g., papillary, RVOT)
• Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause * EC 4 NICM patients only, if any of the following apply:
• Congenital condition that limits access to the left or right ventricles
• Severe aortic or mitral stenosis, severe mitral regurgitation, or severe aortic insufficiency
• Active inflammatory processes (e.g., myocarditis) within the past 120 days
• Sarcoidosis
• Hypertrophic cardiomyopathy
• Drug- or alcohol-induced cardiomyopathy * EC 5 Any VT ablation within 4 weeks prior to enrollment * EC 6 More than one prior (\>4 weeks) VT ablation or prior surgical treatment for VT within the past 2 years * EC 7 Cardiogenic shock, unless it is due to incessant monomorphic VT * EC 8 Any other cardiovascular conditions as described below:
• Class IV heart failure
• Aortic aneurysm
• Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to index procedure
• Interatrial baffle, closure device, patch, or PFO occlusion device
• Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure
• Acute MI or unstable angina in the previous 60 days
• Mechanical mitral or aortic valve
• Cardiac myxoma
• Significant congenital heart disease * EC 9 Acute illness or active systemic infection * EC 10 Any previous history of cryoglobulinemia * EC 11 History of blood clotting or bleeding disease * EC 12 Peripheral vascular disease that precludes LV access * EC 13 Contraindication to heparin * EC 14 Allergy to radiographic contrast dye that cannot be medically managed prior to the ablation procedure * EC 15 Any prior history of documented cerebral vascular accident (CVA), TIA or systemic embolism (excluding a post-operative Deep Vein Thrombosis, DVT), within 6 months prior to the ablation procedure. * EC 16 Pregnant, or anticipated pregnancy during study follow-up * EC 17 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study * EC 18 Any other condition (e.g., ARVC with extensive free wall scarring) that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, candidate for heart transplantation, patient with ventricular assist device, or terminal illness with a life expectancy less than 12 months)
DEVICE: Ultra Low Temperature Ablation (ULTA)
Ventricular Tachycardia, Sustained, Ventricular Tachycardia, Monomorphic
cryoablation, monomorphic VT, sustained monomorphic VT, Ultra Low Temperature Ablation, ULTA
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Study Locations

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Location Contacts
Banner University Medical Center Phoenix Phoenix, Arizona
Brigham and Women's Hospital Boston, Massachusetts
Hospital of University of Pennsylvania Philadelphia, Pennsylvania
McGill University Health Centre (MUHC), Montreal General Hospital (MGH) Montreal, Quebec
Medical Center of South Carolina (MUSC) Charleston, South Carolina
MemorialCare Long Beach Medical Center Long Beach, California Mark Lee, MD - (markyounglee@gmail.com)
Montreal Hear Institute Montreal,
Northwell Health- Staten Island University Hospital Staten Island, New York
Vanderbilt University Medical Center Nashville, Tennessee
Virginia Commonwealth University Richmond, Virginia Ajay Pillai, MD - (ajay.pillai@vcuhealth.org)

A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or - LillyTrials@Lilly.com

NCT07165028
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Inclusion Criteria:
* Have liver fat content ≥8% * Have ELF score of ≥9 and ≤10.8 at screening * Have VCTE LSM ≥10 kilopascal (kPa) and \<20 kPa at screening
Exclusion Criteria:
* Have any other type of liver disease other than MASLD * Have a body mass index (BMI) \<25 kilogram per square meter (kg/m2) * Prior decompensated liver disease (history of esophageal/gastric varices, ascites, hepatic encephalopathy) * Have lost more than 11 pounds within the 3 months prior to screening * Have a hemoglobin A1c (HbA1c) greater than 10% * Have type 1 diabetes
DRUG: Tirzepatide, DRUG: Retatrutide, DRUG: Placebo
Metabolic Dysfunction-associated Steatotic Liver Disease
Nonalcoholic Steatohepatitis, NASH, Fatty Liver, Fatty Liver Disease, SLD, Metabolic Dysfunction-Associated Fatty Liver Disease, MAFLD, Non-alcoholic Fatty Liver Disease, NAFLD, Hepatic Steatosis, Liver Related Outcomes, GLP1, Incretin, Non-Invasive Test
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Study Locations

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Location Contacts
(G.I.R.I.) GI Research Institute Foundation Vancouver,
2nd Affiliated Hospital Chongqing Medical Universi Chongqing,
4 Medical Solutions, Ltd - London London,
4 Medical Solutions, Ltd - Manchester Clifton,
A.O.U. Policlinico Paolo Giaccone Palermo,
AMR Clinical Kansas City, Missouri
AMR Clinical Kansas City, Missouri
AMR Clinical Kansas City, Missouri
AMR Clinical Kansas City, Missouri
AZ Delta vzw Roeselare,
AZ Groeninge Campus Kennedylaan Kortrijk,
AZ Maria Middelares Ghent,
AZ Oostende vzw Ostend,
Abe Clinic Ōita,
Aberdeen Royal Infirmary Aberdeen,
Acharya Vinoba Bhave Rural Hospital Wardha,
Adana Sehir Egitim ve Arastirma Hastanesi Adana,
Advanced Research Institute - Sandy Sandy City, Utah
Affiliated Hospital of Hangzhou Normal University Hangzhou,
Akron Gastro Research Akron, Ohio
All India Institute of Medical Sciences New Delhi,
All India Institute of Medical Sciences New Delhi,
All India Institute of Medical Sciences (AIIMS) - Nagpur Nagpur,
All India Institute of Medical Sciences - Rishikesh Rishikesh,
American Research Corporation Austin, Texas
American Research Corporation at Texas Liver Institute San Antonio, Texas
Amrita Institute of Medical Sciences and Research Center Ernākulam,
Amsterdam UMC, Locatie AMC Amsterdam,
Ankara Bilkent Sehir Hastanesi Ankara,
Antwerp University Hospital Edegem,
Aotearoa Clinical Trials Auckland,
Aotearoa Clinical Trials - Whangarei Whangarei,
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy, Michigan
Ark Clinical Research Long Beach, California
Ark Clinical Research - Fountain Valley Fountain Valley, California
Arkansas Gastroenterology - North Little Rock North Little Rock, Arkansas
Artemis Institute For Clinical Research Riverside, California
Asahikawa Medical University Hospital Asahikawa,
Asan Medical Center Seoul,
Asian Institute Of Gastroenterology Hyderabad,
Associação Protectora dos Diabéticos de Portugal Lisbon,
Assuta Medical Center Tel Aviv,
Atlantic Health System Morristown Medical Center Morristown, New Jersey
Atlantic Medical Penzance,
Austin Health Heidelberg, Victoria
Avant Sante Research Center San Pedro Garza García,
Avron Hospitals Ahmedabad,
Azienda Ospedale - Università Padova Padova,
Azienda Ospedaliera Universitaria Careggi Florence,
Azienda Ospedaliera Universitaria Federico II Naples,
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino Torino,
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Bergamo,
Barwon Health Geelong,
Barzilai Medical Center Ashkelon,
Beijing Ditan Hospital Beijing,
Beijing Friendship Hospital Affiliate of Capital University Beijing, Beijing Municipality
Beijing Youan Hospital Beijing,
Bell Land General Hospital Sakai,
Bellaire Clinical Research Bellaire, Texas
Biopharma Informatic, LLC McAllen, Texas
Biopharma Informatic, LLC McAllen, Texas
Boramae Medical Center Dongjak-gu, Seoul-teukbyeolsi [seoul]
Box Hill Hospital Box Hill,
Bursa Şehir Hastanesi Bursa,
CAMC Health Education and Research Institute Inc Charleston, West Virginia
CEDOES Vitória,
CEINV Salud Monterrey,
CHD Vendee La Roche-sur-Yon,
CHN - Complexo Hospitalar de Niterói Niterói,
CHOP - Hospital Universitario Montecelo Pontevedra,
CHU Besancon Besançon,
CHU Bordeaux Haut-Leveque Pessac,
CHU Rangueil Toulouse,
CHU d'Amiens-Picardie - Hopital SUD Amiens,
CHUAC-Complejo Hospitalario Universitario A Coruña A Coruña, A Coruña [LA Coruña]
CIPREC Buenos Aires,
CPHosp Medicina, Ensino e Pesquisa (CPQuali) São Paulo,
CRIOH Westlake, Ohio
CRZ Vidnovlennya Zhytomyr,
California Liver Research Center Pasadena, California
Capital Digestive Care - Chevy Chase Chevy Chase, Maryland
Care Access - Delray Beach Delray Beach, Florida
Care Access - Houston Houston, Texas
Care Access - New Iberia New Iberia, Louisiana
Care Access - Ogden Ogden, Utah
Care Access - St. Petersburg St. Petersburg, Florida
Care Access - Tamarac Tamarac, Florida
Care Access - Yonkers Yonkers, New York
Care United Research, LLC Forney, Texas
Carmel Hospital Haifa,
Carteret Medical Group Morehead City, North Carolina
Cathay General Hospital Taipei,
Center of Family Medicine Plus Kyiv,
Centre Hospitalier Lyon Sud Pierre-Bénite,
Centre Hospitalier Universitaire Brugmann Brussels,
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand Dijon,
Centre Hospitalier Universitaire d'Angers Angers,
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren Limoges,
Centre Hospitalier Universitaire de Nice - Hopital L'archet Nice,
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes, Ille-et-vilaine
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares Mexico City,
Centro Hospitalar Universitario Lisboa Norte, E.P.E. - Hospital de Santa Maria Lisbon,
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Buenos Aires,
Centro Multidisciplinar de Estudos Clinicos São Bernardo do Campo,
Centro Médico Lic. Arturo Montiel Rojas ISSEMYM Metepec,
Centro Médico Viamonte Buenos Aires,
Centro de Diagnóstico y Rehabilitación (CEDIR) Santa Fe,
Centro de Investigacion y Gastroenterologia Mexico City,
Centro de Investigaciones Clínicas Baigorria Granadero Baigorria,
Centro de Investigaciones Metabólicas (CINME) Buenos Aires,
Centro de Investigación Clínica y Medicina Traslacional (CIMeT) Guadalajara,
Centro de Investigación y Gastroenterología - S.C. Mexico City,
Centro de Pesquisa Clinica do Brasil Lago Sul,
Centrum Badan Klinicznych PI-House Sp. z o.o. Gdansk,
Centrum Medyczne Pratia Katowice Katowice,
Chang Gung Medical Foundation-LinKou Branch Taoyuan,
Chang Gung Memorial Hospital at Kaohsiung Kaohsiung City,
Charite Campus Virchow-Klinikum Berlin,
Charter Research - Orlando Orlando, Florida
Chi Mei Medical Center Tainan,
Chiayi Christian Hospital Chiayi City,
China Medical University Hospital Taichung,
Chronos Pesquisa Clinica Brasília,
Chung-Ang University Hospital Seoul,
Cicemo Srl Buenos Aires,
Cline Research Center Curitiba,
Clinica de Enfermedades Cronicas y Procedimientos Especiales, SC Morelia,
Clinical Diagnostic Center Ivano-Frankivsk,
Clinical Research Institute of Michigan, LLC Clinton Township, Michigan
Clinical Research Institute of Ohio - Brooklyn Brooklyn, Ohio
Clinical Research of Ontario Scarborough Village, Ontario
Clinical Research of Philadelphia Pennington, New Jersey
Clinical Trials of Texas, LLC dba Flourish Research San Antonio, Texas
Cliniques Universitaires Saint-Luc Brussels,
Clínica Hepatogastro JK São Paulo,
Columbia Digestive Health Research Columbia, South Carolina
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval Ferrol,
Consano Clinical Research, LLC Shavano Park, Texas
Constanta County Emergency Clinical Hospital Sf.Ap.Andrei Constanța,
Core Research Group Brisbane,
Cotton O'Neil Digestive Health Center Topeka, Kansas
Covenant Metabolic Specialists - Riverview Riverview, Florida
Covenant Metabolic Specialists, LLC University Park, Florida
DHR Health Institute for Research and Development (Administrative Office & Laboratory) McAllen, Texas
DIM Clinica Privada Ramos Mejía,
DOM Centro de Reumatología Buenos Aires,
Dallas Research Institute Farmers Branch, Texas
Dayanand Medical College and Hospital Ludhiana,
Dayton Gastroenterology - Beavercreek Beavercreek, Ohio
Deaconess Clinic- Gateway Newburgh, Indiana
Debreceni Egyetem Klinikai Kozpont Debrecen,
Del Sol Research Management, LLC Tucson, Arizona
Delta Health Care Bucharest,
Delta Research Partners of Bastrop, LLC Bastrop, Louisiana
Delta Research Partners of West Monroe West Monroe, Louisiana
Deutsches Diabetes-Zentrum (DDZ) Düsseldorf,
Diex Recherche Inc. Division Trois-Rivieres Trois-Rivières,
Diex Recherche Quebec Québec,
Digestive Research Alliance of Michiana South Bend, Indiana
Duke University - Main Hospital and Clinics Durham, North Carolina
E-DA Hospital Kaohsiung City,
ETG Zamosc Zamość,
EUGASTRO GmbH Leipzig,
Ecogene-21 Chicoutimi, Quebec
Edelweiss Medics Kyiv,
Ehime University Hospital Ehime, Toon,
Encore Borland-Groover Clinical Research Jacksonville, Florida
Encore Medical Research Hollywood, Florida
Endolife Speciality Hospitals Guntur,
Epic Medical Research - DeSoto DeSoto, Texas
Epic Medical Research-Sun City Sun City, Arizona
Erasmus Medisch Centrum Rotterdam,
Evolution Clinical Trials Hialeah Gardens, Florida
Excel Clinical Research, LLC Las Vegas, Nevada
Eximia Research - Norfolk Norfolk, Virginia
Faculdade de Medicina da UNESP Botucatu,
Fakultni Nemocnice Ostrava Ostrava,
Fiona Stanley Hospital Murdoch, Western Australia
Flinders Medical Centre Bedford PK, South Australia
Florida Research Institute Lakewood Rch, Florida
Floridian Clinical Research, LLC Miami Lakes, Florida
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan,
Fondazione Policlinico Universitario Agostino Gemelli Roma,
Fondazione Policlinico Universitario Campus Bio-Medico Rome,
Fortis Hospital - Mohali Mohali,
Freeman Hospital High Heaton,
Fresno Clinical Research Center Fresno, California
Fu Jen Catholic University Hospital New Taipei City,
Fujian Medical University Mengchao Hepatobiliary Hospital (Fuzhou Infectious Disease Hospital) Fuzhou,
Fukuoka University Chikushi Hospital Chikushino-shi,
Fukuoka University Hospital Fukuoka, Fukuoka,
Fundacion Respirar Ciudad Autónoma de Buenos Aires, Buenos Aires
Fundación Santos y de la Garza Evia I.B.P San Pedro Garza García, Nuevo León
Fundação Pio XII - Hospital de Câncer de Barretos Barretos,
GI Alliance - Fort Worth Fort Worth, Texas
GI Alliance - Southlake Southlake, Texas
GI Associates - GIA and Endoscopy Center - Flowood Flowood, Mississippi
GI PROS Research Naples, Florida
Galen Medical Group - Galen Hepatology Chattanooga, Tennessee
Gallipoli Medical Research Ltd Brisbane,
Gastro One (Walnut Run Road) Cordova, Tennessee
Gastroenterology Consultants of Southwest Virginia Roanoke, Virginia
Gastroenterology Health Partners New Albany, Indiana
Gastrointestinal Specialists of Georgia Marietta, Georgia
General Hospital of Ningxia Medical University Ningxia,
Genesis Research Services Broadmeadow,
Gifu Municipal Hospital Gifu, Gifu,
Glenny Corp. S.A. Buenos Aires,
Gold Coast University Hospital Southport,
Great Lakes Research Institute Southfield, Michigan
Grupo Medico Camino Sc Mexico City,
Guangzhou 8th People's Hospital Guangzhou,
Guizhou Provincial People's Hospital Guiyang,
Gyeongsang National University Hospital Jinju,
Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero Katowice,
HRI Pasadena Pasadena, Texas
HRI- Medical Center Houston, Texas
Hacettepe Universitesi Ankara,
Hadassah Medical Center Jerusalem,
Hamamatsu University Hospital Shizuoka, Hamamatsu,
Hamanomachi Hospital Fukuoka,
Hanyang University Guri Hospital Guri-si,
Hanyang University Seoul Hospital Seoul,
Headlands Horizons, LLC dba Headlands Research-Brownsville Brownsville, Texas
Headlands Research Orlando Orlando, Florida
Health Awareness Jupiter, Florida
Health Sciences Centre Winnipeg Winnipeg,
Heritage Medical Research Clinic Calgary,
Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen Bad Oeynhausen,
Hiroshima University Hospital Hiroshima,
Hokkaido University Hospital Hokkaido, Sapporo,
Hopital Beaujon Clichy,
Hopital Claude Huriez - CHU de Lille Lille, NORD
Hopital Saint Antoine Paris,
Hospital Brasilia Lago Sul,
Hospital Clinico de Valencia Valencia,
Hospital General Universitario Gregorio Marañon Madrid,
Hospital General de Occidente Zapopan,
Hospital Germans Trias I Pujol Badalona, Barcelona [barcelona]
Hospital Infanta Elena Huelva,
Hospital Moinhos de Vento Porto Alegre, Rio Grande do Sul
Hospital Universitari Son Espases Palma,
Hospital Universitari Vall d'Hebron Barcelona,
Hospital Universitari i Politécnic La Fe Valencia,
Hospital Universitario Joao de Barros Barreto Belém,
Hospital Universitario La Paz Madrid,
Hospital Universitario Marqués de Valdecilla Santander,
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario Walter Cantidio Fortaleza,
Hospital das Clinicas FMUSP São Paulo,
Hospital de Clínicas de Porto Alegre Bairro Santa Cecília, Rio Grande do Sul
Houston Research Institute Houston, Texas
Houston Research Institute (HRI) - Sugar Land Sugar Land, Texas
Hunan Provincial People's Hospital Changsha,
Hyogo Medical University Hospital Nishinomiya,
Hyogo Prefectural Amagasaki General Medical Center AmagasakiCity, Hyōgo
IBPClin - Instituto Brasil de Pesquisa Clínica Rio de Janeiro,
ID Clinic Mysłowice,
IMA Clinical Research Austin Austin, Texas
IMA Clinical Research Manhattan New York, New York
IMA Clinical Research San Antonio San Antonio, Texas
IMA Clinical Research Warren Warren Township, New Jersey
IMV Pesquisa Cardiologica - Porto Alegre - Rua Orfanotrofio Porto Alegre,
INECO Neurociencias Oroño Rosario,
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola Bologna,
IRCCS Istituto Clinico Humanitas Rozzano,
Indiana University Health University Hospital Indianapolis, Indiana
Inha University Hospital Incheon,
Inovace Pesquisa Clínica Salvador,
Institute of Science Tokyo Hospital Tokyo,
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City,
Instituto Veracruzano en Investigación Clínica S.C. Veracruz,
Instituto de Diabetes, Obesidad y Nutricion Cuernavaca,
Instituto de Investigaciones Clinicas Mar del Plata Mar del Plata,
Instituto de Investigaciones Clínicas Córdoba Córdoba,
Instituto de Investigaciones Clínicas Rosario Rosario,
Instituto de Pesquisa Clinica de Campinas Campinas,
Instituto do Fígado e Tranplantes de Pernambuco Recife,
Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor Cluj-Napoca,
International University of Health and Welfare Narita Hospital Narita, Chiba
Iowa Diabetes and Endocrinology Research Center West Des Moines, Iowa
Ipswich Hospital Ipswich,
Ipswich Hospital Ipswich,
Isis Clinical Research Center Guaynabo,
Iwate Medical University Hospital Shiwa-gun,
Japanese Red Cross Musashino Hospital Musashino,
Jiangsu Province Hospital Nanjing, Jiangsu
Jichi Medical University Hospital Shimotsuke,
Jinhua Central Hospital Jinhua,
John C. Martin Centre for Liver Research & Innovations (JCMLRI) Kolkata,
Johnson County Clinical Trials Lenexa, Kansas
Jubilee Clinical Research NV. LLC Las Vegas, Nevada
Juntendo University Hospital Tokyo,
Juntendo University Shizuoka Hospital Shizuoka, Izunokuni,
K2 MEDICAL Research THE VILLAGES Lady Lake, Florida
K2 Medical Research - Daytona Beach Daytona Beach, Florida
K2 Medical Research WINTER GARDEN Clermont, Florida
KRESMED Sp. z o.o. Bialystok,
Kagawa Prefectural Central Hospital Takamatsu-shi, Kagawa,
Kagawa University Hospital Kita-gun,
Kagoshima University Hospital Kagoshima,
Kansai Rosai Hospital Amagasaki,
Kantonsspital Olten Olten,
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City,
Karadeniz Teknik Universitesi Tip Fakultesi Trabzon,
Keimyung University Dongsan Hospital Daegu, Taegu-kwangyǒkshi
King's College Hospital London,
Klinical Investigations Group San Juan,
Klinik Landstraße Vienna,
Knowledge Research Center Orange, California
Kohler & Milstein Research S.A. De C.V. Mérida,
Korea University Ansan Hospital Ansan-si, Kyǒnggi-do
Krajská nemocnice Liberec Liberec,
Kumamoto Shinto General Hospital Kumamoto,
Kumamoto University Hospital Kumamoto,
Kurume University Hospital Fukuoka, Kurume,
Kyungpook National University Hospital Daegu,
Landesklinikum Wiener Neustadt Wiener Neustadt,
Liaocheng People's Hospital Liaocheng,
Limited liability company "Medical center Health Clinic" Vinnytsia,
Lisie Hospital Kochi,
Liverpool University Hospitals NHS Foundation Trust Liverpool,
Los Angeles Institute for Metabolic Research Los Angeles, California
Louisiana Research Center Shreveport, Louisiana
Lucida Clinical Trials New Bedford, Massachusetts
MFA Clinical Research Tuscaloosa, Alabama
MNGI Digestive Health Minneapolis, Minnesota
MTZ Clinical Research powered by Pratia Warsaw,
Maccabi Health Services - Petah Tikva Petah Tikva,
Mater Misericordiae Limited Brisbane,
Mautalen Salud e investigación Buenos Aires,
Medbud Clinic Kyiv,
Medical Associates Research Group San Diego, California
Medical Center - Arcus Medical Veliko Tarnovo,
Medical Center Metas Chihuahua City,
Medical Center Ok!Clinic+ Kyiv,
Medical Center Salutem Vinnytsia,
Medical Center of Limited Liability Company "Medical Center "Consilium Medical" Kiev,
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś Warsaw,
Medical Research Center of Connecticut Hamden, Connecticut
Medizinische Hochschule hannover Hanover,
Medizinische Universität Graz Graz,
Medizinische Universität Wien Vienna,
Medrasa Clinical Research Wylie, Texas
Meitetsu Hospital Nagoya,
Mercy Medical Center - Baltimore Baltimore, Maryland
Mestska nemocnice Ostrava Ostrava,
Midas Multispeciality Hospital Pvt.Ltd. Nagpur,
Mie University Hospital Tsu,
Monroe Biomedical Research Monroe, North Carolina
Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia Regio -T Vinnytsia,
Mysore Medical College Mysore,
NUPEC - Cardio Belo Horizonte,
NYU Langone Health New York, New York
NZOZ GynCentrum - Oddział Warszawa Warsaw,
Nagano Municipal Hospital Hanishina-gun,
Nagasaki University Hospital Nagasaki,
Nagoya City University Hospital Nagoya,
Nara Medical University Hospital Nara, Kashihara,
National Center for Global Health and Medicine Shinjuku, Tokyo
National Cheng Kung University Hospital Tainan,
National Hospital Organization Nagasaki Medical Center Ōmura, Nagasaki
National Hospital Organization Osaka National Hospital Osaka-Shi Chuo-Ku, Osaka
National Hospital Organization Takasaki General Medical Center Takasaki-shi,
National Hospital Organization Ureshino Medical Center Ureshino,
National Kohnodai Medical Center Ichikawa,
National Taiwan University Hospital Taipei,
Nature Coast Clinical Research - Inverness Inverness, Florida
New York Gastroenterology Associates New York, New York
New Zealand Clinical Research (Auckland) Auckland,
NewData Clinical Research - Aracaju Aracaju,
Nightingale Research Adelaide,
Nihon University Itabashi Hospital Tokyo,
Ningbo 2nd Hospital Ningbo,
Ningbo Medical Center Ningbo,
Nouvel Hôpital Civil (NHC) Strasbourg,
Ogaki Municipal Hospital Gifu, Ogaki,
Oita Cardiovascular Hospital Ōita,
Okayama University Hospital Okayama,
Om Research LLC Oxnard, California
Oncare Vasconcelos San Pedro Garza García,
Orange County Research Center Lake Forest, California
Osaka General Medical Center Osaka,
Osaka Keisatsu Hospital Osaka,
Osaka Metropolitan University Hospital Osaka,
Osaka Rosai Hospital Sakai,
Osaka Saiseikai Suita hospital Suita,
Oslo Universitetssykehus Ullevål Oslo,
Panthera Biopartners - Glasgow Glasgow,
Panthera Biopartners - Manchester Rochdale,
Panthera Biopartners - North London Enfield,
Panthera Biopartners - Preston Preston,
Panthera Biopartners - Sheffield Sheffield,
Panthera Clinic - York York,
Państwowy Instytut Medyczny MSWiA Warsaw,
Peking University People's Hospital Beijing,
Peking University Shenzhen Hospital Shenzhen, Guangdong
Penn Medicine: University of Pennsylvania Health System Philadelphia, Pennsylvania
PingXiang People's Hospital Pingxiang,
Pinnacle Clinical Research Austin, Texas
Pitie Salpetriere University Hospital Paris,
Policlinico GB Rossi Borgo Roma Verona,
Postgraduate Institute of Medical Education & Research Chandigarh,
Prince of Wales Hospital Randwick, New South Wales
Private Practice - Dr. Arechavaleta Granell Maria del Rosario Guadalajara,
Private Practice - Dr. Lukasz Krupa Rzeszów,
Private Practice - Dr. Stephane M. Gauthier North Bay,
Progastro Clinic Lviv,
Progress Clinical Research - Den Bosch 's-Hertogenbosch,
Progress Clinical Research - Zwolle Zwolle,
Progressive Medical Research Port Orange, Florida
Przychodnie Care Access Warsaw,
Pusan National University Yangsan Hospital Busan,
QEII Health Sciences Centre - Victoria General Site Halifax,
Queen Mary Hospital Hong Kong,
Quest Clinical Research San Francisco, California
Rabin Medical Center Petah Tikva, Central District
Radboudumc Nijmegen,
Rambam Health Care Campus Haifa,
Recep Tayyip Erdogan University Training and Research Hospital Rize,
Research Foundation of SUNY - University of Buffalo Buffalo, New York
Research Physicians Network, LLC Houston, Texas
Richmond Veterans Affairs Medical Center (Richmond VA Medical Center) Richmond, Virginia
Rophe Adult and Pediatric Medicine/SKYCRNG Union City, Georgia
Royal Brisbane and Women's Hospital Herston, Queensland
Royal Free Hospital London,
Royal London Hospital London,
Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai,
Ruppiner Kliniken Neuruppin,
Ruschel Medicina e Pesquisa Clínica Rio de Janeiro,
SR Kalla Memorial Gastro & General Hospital Jaipur,
Saga University Hospital Saga,
Saint Marina Hospital Pleven,
Saiseikai Maebashi Hospital Maebashi,
Samsung Medical Center Seoul,
San Fernando Valley Health Institute Canoga Park, California
Sanjay Gandhi Post Graduate Institute of Medical Sciences Lucknow,
Santa Familia PTG Lodz Lodz,
Sekino Hospital Toshimaku,
Seoul National University Hospital Seoul,
Severance Hospital, Yonsei University Health System Seoul,
Severance Hospital, Yonsei University Health System Seoul,
Shaare Zedek Medical Center Jerusalem,
Sheba Medical Center Ramat Gan,
Shengjing Hospital of China Medical University Shenyang,
Shimane University Hospital Izumo,
Sichuan Provincial People's Hospital Chengdu,
Sir Ganga Ram Hospital New Delhi,
Soma Clinical Trials Denison, Texas
Soon Chun Hyang University Bucheon Hospital Bucheon-si,
Soroka Medical Center Beersheba,
Sourasky Medical Center Tel Aviv,
South Denver Gastroenterology Englewood, Colorado
South Texas Research Institute Edinburg, Texas
South Texas Research Institute - Brownsville Brownsville, Texas
Southeast Clinical Research Center Dalton, Georgia
Southern Endocrinology Associates Mesquite, Texas
Southern Medical University Nanfang Hospital Guangzhou, Guangdong
Southwest Gastroenterology Associates Albuquerque, New Mexico
Southwest General Healthcare Center Fort Myers, Florida
Spectrum Research Institute Gilbert, Arizona
Spital Judetean de Urgenta Satu Mare,
Spitalul Clinic Colentina Bucharest,
St. Joseph's Health Centre Toronto,
St. Marianna University Hospital Kawasaki-shi,
Surat Institute of Digestive Sciences Hospitals Surat,
Szabolcs Szatmár Bereg Vármegyei Oktatókórház Nyíregyháza,
Szpital Czerniakowski Warsaw,
T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik Eğitim Ve Araştirma Hastanesi Pendik,
Taichung Veterans General Hospital Taichung,
Taipei Medical University Hospital Taipei,
Taipei Tzu Chi General Hospital New Taipei City,
Taipei Veterans General Hospital Taipei,
Tampa Bay Medical Research - Largo Largo, Florida
Tandem Clinical Research Marrero, Louisiana
Tandem Clinical Research - Freehold Freehold, New Jersey
Texas Valley Clinical Research Weslaco, Texas
The Affiliated Hospital of Guizhou Medical University Guiyang,
The Affiliated Hospital of Southwest Medical University Luzhou,
The Catholic Univ. of Korea Seoul St. Mary's Hospital Seoul, Seoul-teukbyeolsi [seoul]
The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul, Seoul-teukbyeolsi [seoul]
The Cognitive and Research Center of New Jersey - Ridgewood Ridgewood, New Jersey
The First Affiliated Hospital of Henan University of Science &Technology Luoyang,
The First Affiliated Hospital of Nanyang Medical College Nanyang,
The First Affiliated Hospital of Ningbo University Ningbo,
The First Affiliated Hospital of Wenzhou Medical University Wenzhou,
The First Affiliated Hospital of Xi'An Jiaotong University Xi'an, Shaanxi
The First Affiliated hospital of Fujian Medical University Fuzhou,
The First People's Hospital of Foshan Foshan,
The First affiliated hospital of Nanchang University (Xianghu campus) Nanchang,
The Institute for Liver Health II dba Arizona Clinical Trials - Chandler Chandler, Arizona
The Institute for Liver Health II dba Arizona Clinical Trials - Tucson Tucson, Arizona
The Institute for Liver Health II dba Arizona Liver Health - Peoria Peoria, Arizona
The John Radcliffe Hospital Oxford,
The Royal Melbourne Hospital Parkville,
The Second Affiliated Hospital of Nanchang University Nanchang, Jiangxi
The Second Xiangya Hospital of Central South University Changsha,
The Third Hospital of Hebei Medical University Shijiazhuang,
The University of Osaka Hospital Suita-shi,
The University of Tokyo Hospital Bunkyō City,
Tianjin People' s Hospital Tianjin,
Tokyo Medical University Hospital Tokyo,
Tokyo Metropolitan Komagome Hospital Bunkyō City,
Tokyo Saiseikai Central Hospital Minatoku,
Tokyo Women's Medical University Tokyo,
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital Mumbai,
Toranomon Hospital Tokyo, Minato-ku,
Toronto General Hospital Toronto, Ontario
TrialsWest - Osborne Park Osborne Park,
Tuen Mun Hospital Hong Kong,
UCSD - Altman Clinical and Translational Research Institute (ACTRI) La Jolla, California
UMHATEM 'N.I. Pirogov' Sofia,
US Digestive Health - Flourtown Flourtown, Pennsylvania
US Digestive Health - Wyomissing Wyomissing, Pennsylvania
UW Medicine Diabetes Institute Seattle, Washington
UZ Brussel Brussels, Brussels Capital
UZ Gent Ghent,
Unidad de Investigación Clínica y Atención Médica HEPA S.C. Guadalajara,
Uniklinikum Salzburg Salzburg,
United Medical Doctors - Murrieta Murrieta, California
Universidade Federal de Goias Goiânia,
Universidade Federal do Rio de Janeiro Barra,
UniversitaetsKlinikum Heidelberg Heidelberg,
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden Dresden, Saxony
Universitaetsklinikum Des Saarlandes Homburg,
Universitair Medisch Centrum Utrecht Utrecht,
Universitatsklinikum Leipzig Leipzig,
Universitetssjukhuset i Linköping Linköping,
Universitetssykehuset Nord-Norge HF Tromsø,
University Gastroenterology Providence, Rhode Island
University Hospital - London Health Sciences Centre London,
University Hospital Basel Basel,
University Hospital,Kyoto Prefectural University of Medicine Kyoto,
University of Alberta Hospital Edmonton, Alberta
University of Chicago Medical Center Chicago, Illinois
University of Colorado Anschutz Medical Campus Aurora, Colorado
University of Florida College of Medicine Jacksonville, Florida
University of the Ryukyus Hospital Ginowan,
Universitätsklinikum Brandenburg an der Havel Brandenburg,
Universitätsklinikum Frankfurt Goethe-Universität Frankfurt,
Universitätsmedizin Johannes Gutenberg Universität Mainz Mainz,
Université Libre de Bruxelles - Hôpital Erasme Brussels, Bruxelles-capitale, Région de
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Poznan,
VITAZ Sint-Niklaas,
Vancouver General Hospital Vancouver, British Columbia
Virginia Commonwealth University (VCU) Medical Center Richmond, Virginia
Vseobecna Fakultni Nemocnice v Praze Prague,
Washington Gastroenterology - Bellevue Bellevue, Washington
Washington Gastroenterology - Tacoma Tacoma, Washington
Wells Research Group Edmonton,
Westmead Hospital Westmead, New South Wales
Wonju Severance Christian Hospital Wŏnju, Kang-won-do
Xiangya Hospital Central South University Changsha,
Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine Shanghai,
Yamagata University Hospital Yamagata, Yamagata
Yamanashi Prefectural Central Hospital Kofu,
Yeungnam Univeristy Medical Center Daegu,
Yokohama City University Hospital Yokohama,
Zhongshan Hospital,Fudan University Shanghai,
Zhoukou Central Hospital Zhoukou,
hospital Italiano de Buenos Aires ABB, Buenos Aires F.D.
Çukurova Üniversitesi Tıp Fakültesi Adana Hastanesi Adana,
Óbudai Egészségügyi Centrum Budapest,

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

Novartis Pharmaceuticals - novartis.email@novartis.com

NCT06846281
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Key
Inclusion Criteria:
* Male or female aged 40 to 70 years (inclusive) * Diagnosis of RMS according to the 2017 McDonald diagnostic criteria * Treated with ocrelizumab according to routine clinical practice and at standard dose * Neurologically stable within 30 days * Suitable to be switched to remibrutinib based on physician judgement or patient preference Key
Exclusion Criteria:
* Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria * History of clinically significant Central Nervous System disease or neurological disorders * History of confirmed Progressive Multifocal Leukoencephalopathy or neurological symptoms consistent * Active clinically significant systemic bacterial, viral, parasitic or fungal infections * Active, chronic disease of the immune system other than MS * Severe cardiac disease or significant findings on the ECG * Participant who is unable to undergo MRI scans * History of life-threatening infusion or injection reaction related to ocrelizumab * Participants not adequately controlled on ocrelizumab (CD19+ B-cell count ≥10 cells/µL at screening) Other inclusion and exclusion criteria may apply
DRUG: Remibrutinib oral treatment, DRUG: Ocrelizumab
Relapsing Multiple Sclerosis
MS, RMS, Remibrutinib, LOU064, Ocrelizumab, Age, MRI, T2 lesions, NEDA-3
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Advent Health Orlando Orlando, Florida McKinzie McTyeire - (mckinzie.mctyeire@adventhealth.com)
Aqualane Clinical Research Naples, Florida Taylor Kerskie - (taylor@aqualaneresearch.com)
Austin Regional Clinic Austin, Texas Katerina Rodriguez - (krodriguez@innovoresearch.com)
Center for Neurological Disorders G Greenfield, Wisconsin Emily Barraza - (Emily.barraza@cndmilwaukee.com)
Cleveland Clinic Foundation Cleveland, Ohio Laurinda Keelen - (keelenl@ccf.org)
Cleveland Clinic Foundation Cleveland, Ohio Dawn Maniawski - (maniawd@ccf.org)
Elite Clinical Research Jackson, Mississippi Rebeca Fernandez - (rfernandez@eliteclinicalresearch.com)
Holy Name Medical Center Teaneck, New Jersey Diome Kramer - (dkramer@holyname.org)
John Peter Smith Hospital Fort Worth, Texas Valentina Jovic - (Vjovic@jpshealth.org)
Lahey Hospital and Medical Center Burlington, Massachusetts Anish Panda - (Anish.Panda@lahey.org)
MedStar Montgomery Medical Center Olney, Maryland Yemisrach Tadesse - (yemisrach.g.tadesse@medstar.net)
Medical College of Wisconsin Milwaukee, Wisconsin Anna Freiberg - (afreiberg@mcw.edu)
Medstar Washington Hospital Center Washington D.C., District of Columbia Anu Bhooshan - (anu.r.bhooshan@medstar.net)
Memorial HC Ins for Neuroscience Owosso, Michigan Samantha Katt - (skatt@memorialhealthcare.org)
Memorial Healthcare System Pembroke Pines, Florida Hina Khan - (hikhan@mhs.net)
Michigan Institute of Neurological Farmington Hills, Michigan Emily Blazejewski - (eblazejewski@mindonline.com)
Neurology Associates PA Maitland, Florida Kelly Holley - (admin@naparesearch.com)
Neurology Center of New England PC Foxborough, Massachusetts Brianne Calitri - (bcalitri@neurocenterne.com)
Neurology of Central FL Res Ctr Altamonte Springs, Florida Adiana Perez - (adiresearchcfl@gmail.com)
Novartis Investigative Site Leicester,
Novartis Investigative Site Leicester,
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Novartis Investigative Site Leicester,
Ohio Health Research Institute Columbus, Ohio Megan Heckathorn - (Megan.Heckathorn@ohiohealth.com)
Orlando Health Clinical Trials Orlando, Florida Charlene Carlo - (Charlene.carlo@orlandohealth.com)
Perseverance Research Center Scottsdale, Arizona Adriana Romero - (aromero@prcresearcheducation.com)
Premier Health Centerville, Ohio Don McHone - (djmchone@premierhealth.com)
Premier Neurology Greenville, South Carolina Jada Crawford - (jada.c@premier-neuro.com)
Providence Neurological Services West Portland, Oregon Hunter Weaver - (hunter.weaver@providence.org)
Rush University Medical Center Chicago, Illinois Bartosz Jacher - (Bartosz.Jacher@Northwestern.edu)
SUNY Buffalo The Jacobs Neuro Inst Buffalo, New York Kara Patrick - (kpatrick@buffalo.edu)
Sanford Health Sioux Falls, South Dakota Destini Spaeth - (destini.spaeth@sanfordhealth.org)
Saturn Research Solutions LLC Plano, Texas Maxine Fligg - (mfligg@saturnclinical.com)
Sibyl Wray MD Neurology PC Knoxville, Tennessee Kim Puccio - (kpuccio@hopeneuro.com)
Tallahassee Neurological Clinic Tallahassee, Florida Sharon Devore - (sharondevore@hotmail.com)
Tufts Medical Center Boston, Massachusetts
Univ of Cincinnati Medical Center Cincinnati, Ohio Gideon Gyebi - (gyebign@ucmail.uc.edu)
Univ of Texas Southwest Med Center Dallas, Texas Manuel Huichapa - (manuel.huichapa@utsouthwestern.edu)
University of California Irvine Irvine, California Veronica Martin - (vero@hs.uci.edu)
University of Chicago Chicago, Illinois Cheryl Bibbs - (cbibbs@bsd.uchicago.edu)
University of Florida Gainesville, Florida Whitney Miller - (wjm1433@ufl.edu)
University of Kansas Hospital Kansas City, Kansas Vonda Whitley - (vwhitley@kumc.edu)
University of New Mexico Albuquerque, New Mexico Emily Reese - (ejreese@salud.unm.edu)
University of South Florida Tampa, Florida Amber McPherson - (amjackson@usf.edu)
Velocity Clinical Research Omaha, Nebraska Harsh Patel - (HPatel@velocityclinical.com)
Vero Beach Neurology Vero Beach, Florida Clellia Bergamino - (cbergamino@geodysseyrsch.com)
Virginia Commonwealth University Richmond, Virginia Aarati Pokharel - (aarati.pokharel@vcuhealth.org)
WA Uni School Of Med St Louis, Missouri Kiontay Watson - (k.watson@wustl.edu)

Modeling Mortality in Duchenne Muscular Dystrophy Cardiomyopathy: Identification of Surrogate Outcome Measures for DMD Drug Trials

Jonathan Soslow, MD, MSCI - DMDMachineLearning@vumc.org

NCT07674758
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Inclusion Criteria:
* Clinical phenotype of Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), or muscular dystrophy carrier (MDC) confirmed with muscle biopsy or genotype
Exclusion Criteria:
* Additional genetic or congenital abnormality that may affect cardiovascular function or progression * Current investigational therapy that may affect cardiovascular function (would preclude ongoing data collection but prior data would still be used)
Duchenne Muscular Dystrophy (DMD), Cardiomyopathy, Becker Muscular Dystrophy, Carrier of Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy, cardiomyopathy, machine learning, cardiac MRI, Biomarker, Outcome measures
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Children's Hospital of Richmond at VCU Richmond, Virginia Study Coordinator - (DMDmachinelearning@vumc.org)
Children's National Washington D.C., District of Columbia Study Coordinator - (DMDmachinelearning@vumc.org)
Duke Children's Hospital Durham, North Carolina Study Coordinator - (DMDmachinelearning@vumc.org)
Lurie Children's Chicago, Illinois
Nationwide Children's Columbus, Ohio Study Coordinator - (DMDmachinglearning@vumc.org)
Riley Children's Hospital Indianapolis, Indiana Study Coordinator - (DMDMachineLearning@vumc.org)
Seattle Children's Seattle, Washington Study Coordinator - (DMDmachinelearning@vumc.org)
UC Davis Sacramento, California Study Coordinator - (DMDmachinelearning@vumc.org)
Vanderbilt University Medical Center Nashville, Tennessee Study Coordinator - (DMDMachineLearning@vumc.org)

Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma

Clinical Trials Administrator - clinicaltrials@regeneron.com

NCT06585410
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Inclusion Criteria:

• Participants who have a histologically confirmed invasive CSCC TL, as described in the protocol
• Participants who have CSCC TL ≥1 cm and ≤2.0 cm (longest diameter) prior to biopsy and \>0.7 cm to ≤2.0 cm after biopsy, located in either the Head or Neck (HN), hand, or pre-tibial surface, as described in the protocol
• Participants who are judged to be eligible for surgical resection of their CSCC TL and the method of planned surgical resection would be Micrographically oriented histographic surgery (Mohs) or other surgical method of Complete Margin Assessment (CMA). Participants for whom the planned surgery is surgical excision without margin control are not eligible
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
• Adequate hepatic, renal and bone marrow functions, as described in the protocol Key
Exclusion Criteria:

• Participant in which the TL is a keratoacanthoma (KA), adenosquamous carcinoma, desmoplastic carcinoma, sarcomatoid carcinoma, basal cell carcinoma, basosquamous carcinoma, Bowen's disease, or CSCC in situ without an invasive component. (Note: For participants with invasive CSCC with a minor basaloid component, the patient may be eligible after discussion with the sponsor medical director.)
• Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated Adverse Events (imAEs), as described in the protocol
• History of non-infectious pneumonitis within the last 5 years
• TL (lesion planned for intralesional therapy) or other non-target CSCC lesion in dry red lip (vermillion), oral cavity, or nasal mucosa NOTE: Other protocol defined inclusion / exclusion criteria apply.
DRUG: Cemiplimab, PROCEDURE: Standard of care
Cutaneous Squamous Cell Carcinoma (CSCC)
Dermato-Oncology, Cemiplimab, Early Stage, Skin Cancer, Non-Melanoma Skin Cancer, UV Skin Damage, Chronic Sun Exposure
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Arkansas Research Trials North Little Rock, Arkansas
Buckeye Dermatology - Springfield Office Springfield, Ohio
Center for Clinical Studies at Webster Clear Lake Webster, Texas
Cleveland Clinic Cleveland, Ohio
Clinical Research Center of the Carolinas Charleston, South Carolina
Columbia University Medical Center - Herbert Irving Center for Dermatology and Skin Cancer - Herbert Irving Pavilion New York, New York
Dana-Farber Cancer Institute Boston, Massachusetts
Dawes Fretzin Clinical Research - Shadeland Ave. Indianapolis, Indiana
Dermatology Associates of the Palm Beaches, Integri Research at Dermatology Associates Delray Beach, Florida
Dermatology Health Specialists Bend, Oregon
Dermatology Institute of Victoria (DIV) South Yarra, Victoria
Dermatology and Skin Cancer Center Lee's Summit, Missouri
Epiphany Dermatology Lewisville, Texas
Equity Medical, LLC Bowling Green, Kentucky
Fremantle Dermatology Fremantle, Western Australia
George Washington University Medical Faculty Associates Washington D.C., District of Columbia
Las Vegas Dermatology Las Vegas, Nevada
Life Clinical Trials Coral Springs, Florida
Mayo Clinic - Arizona Scottsdale, Arizona
Medical Dermatology Specialists - Phoenix Phoenix, Arizona
Memorial Sloan Kettering Cancer Center New York, New York
Metropolitan Dermatology Clark, New Jersey
MyMichigan Dermatologic Oncology Midland, Michigan
Northeast Dermatology Associates Beverly, Massachusetts
Oak Dermatology Naperville, Illinois
Oregon Health & Science University Portland, Oregon
Peak Dermatology, Aesthetics and Wellness Visalia, California
Penn Medicine, Perelman Center For Advanced Medicine Philadelphia, Pennsylvania
Penn State Hershey Medical Center Hershey, Pennsylvania
Princess Alexandra Hospital Woolloongabba, Queensland
Profound Research, Dermatology Medical Group - Oceanside Oceanside, California
Reveal Research Institute Dallas, Texas
Rochester Dermatologic Surgery, P.C. Victor, New York
Somerset Skin Centre Troy, Michigan
Stanford University Palo Alto, California
StracSkin, PLLC Portsmouth, New Hampshire
Texas Dermatology and Laser Specialists San Antonio, Texas
The Skin Hospital Darlinghurst, New South Wales
The University of Texas MD Anderson Cancer Center Houston, Texas
The University of Texas at Austin Dell Medical School Ascension Medical Group Austin, Texas
U.S. Dermatology Partners Cedar Park, Texas
UC San Diego Moores Cancer Center La Jolla, California
UNC Hospitals Dermatology and Skin Cancer Center at Southern Village Chapel Hill, North Carolina
US Dermatology Partners DBA DermAssociates, PC Rockville, Maryland
University of Arizona Cancer Center Tucson, Arizona
University of Chicago Medical Center Chicago, Illinois
University of New Mexico Albuquerque, New Mexico
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma
University of South Florida Tampa, Florida
University of Utah Hospital Salt Lake City, Utah
VCU Massey Cancer Center Richmond, Virginia
Washington University in St. Louis - Center for Dermatologic and Cosmetic Surgery St Louis, Missouri
Westmead Hospital Westmead, New South Wales

Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy (GAIN-BCG)

Aishwarya Vijendran - guprotocols@alliancenctn.org

NCT07000084
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Inclusion Criteria:
* Documentation of Disease: Histologic confirmation of urothelial carcinoma that is high grade Ta, high grade T1, or Tis (Tis/carcinoma in situ \[CIS\] only disease) within 120 days prior to randomization * Any component of neuroendocrine carcinoma (i.e., small cell or large cell) is not allowed. Other histologic subtypes/variant histologies are allowed so long as there is a predominantly urothelial component. \* Note: Pure squamous cell carcinoma or pure adenocarcinoma without a urothelial component are not allowed * All visible papillary lesions must be macroscopically resected by TURBT within 90 days of randomization. (Residual CIS is permitted). \* If the treating urologist did not perform the TURBT, the treating urologist must perform a cystoscopy within 45 days prior to randomization to confirm the absence of visible papillary disease * All patients with high grade T1 must undergo a restaging TURBT within 90 days of randomization. Patients who undergo a restaging TURBT that shows no residual cancer in the specimen are still eligible for trial based on prior TURBT * Patients must have BCG-Exposed non muscle invasive bladder carcinoma (NMIBC), defined as recurrent high grade NMIBC within 24 months of last BCG exposure but not meeting the definition of BCG unresponsive disease * Note: Up to 26 months from the last BCG instillation is allowed for the treating physician to perform a transurethral resection of bladder tumor (TURBT) so long as there is evidence/suspicion of recurrent disease (by positive cytology, imaging, or cystoscopy) within 24 months of last exposure to BCG. * Note: A patient who previously met the definition of BCG unresponsive NMIBC but no longer currently meets unresponsive criteria may still enroll in this trial so long as the treating urologist believes re-treatment with BCG is a reasonable treatment option for that patient. * BCG-exposed NMIBC criteria is defined as: * Any high grade NMIBC recurrence within 24 months of induction only BCG, or * A high grade papillary NMIBC (Ta/T1) recurrence between 6-24 months of last exposure to induction + maintenance BCG, or * A high-grade CIS (with or without Ta/T1 papillary disease) recurrence within 12-24 months of last exposure to induction + maintenance BCG. * Patient must not have BCG-unresponsive NMIBC, defined as: * Persistent or recurrent high-grade papillary NMIBC (Ta/T1) \< 6 months of "adequate" BCG, or * A high-grade CIS (with or without Ta/T1 papillary disease) recurrence \< 12 months of "adequate" BCG, or * A high grade T1 recurrence at the first 3-month assessment from induction BCG * "Adequate" BCG is defined as ≥5 of 6 doses of induction BCG therapy with either * ≥ 2 of 3 doses of maintenance BCG, or * ≥ 2 of planned 6 instillations of repeat induction BCG given within a 6 month time period * More than one prior induction course of BCG and/or prior maintenance BCG is allowed so long as the patient does not currently met the definition of BCG unresponsive disease * Prior treatment with any intravesical chemotherapy (both perioperative and induction course) for NMIBC is allowed, including gemcitabine either alone or in combination (ie. gemcitabine plus docetaxel) or gemcitabine delivered through a intravesical delivery system (ie. TAR-200) * Prior treatment with any systemic or intravesical agents for NMIBC is allowed, regardless of whether it is given either alone or in prior combination with BCG (ie. Prior treatment with pembrolizumab, other immune checkpoint inhibitors, nadofaragene firadenovec, nogapendekin alfa inbakicept, cretostimogene grenadenorepvec, etc. are all allowed) * Patients must not have a history of intolerance to BCG (ie needing to stop BCG induction or maintenance due to toxicity) or intolerance to any other intravesical therapies * Patients must not have compromised bladder function such that they are unlikely to tolerate further intravesical therapies * Patient must not have any prior history or current evidence of muscle-invasive (i.e., T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on radiographic imaging obtained within 120 days prior to randomization. \* The radiographic imaging includes a CT Scan or MRI of the abdomen/pelvis with intravenous contrast, with a CT or MRI urogram preferred. If a patient is unable to receive intravenous contrast due to renal function or allergy, then either a CT scan or MRI of the abdomen/pelvis without intravenous contrast is acceptable * Patients with a history of upper tract urothelial carcinoma are allowed so long as they had localized non-muscle invasive (Ta, T1, Tis) that has been definitively treated with surgery (nephroureterectomy or ureterectomy) with at least one post-treatment disease assessment imaging study that demonstrates no evidence of residual upper tract disease * Patients with a history of, or current evidence of, non-invasive (Ta/Tis) urothelial carcinoma of the prostatic urethra are eligible so long as a transurethral resection of prostate (TURP) is performed before enrollment and there is prostatic glandular tissue without evidence of lamina propria invasion or prostatic stromal invasion * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * Age ≥ 18 years * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Not pregnant and not nursing, Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: * has achieved menarche at some point * has not undergone a hysterectomy or bilateral oophorectomy * has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
BIOLOGICAL: BCG Solution, PROCEDURE: Biopsy of Bladder, PROCEDURE: Cystoscopy, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Biospecimen Collection, PROCEDURE: Transurethral Resection of Bladder Tumor, DRUG: Gemcitabine
Recurrent Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
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Banner MD Anderson Cancer Center Gilbert, Arizona
Benefis Helena Specialty Center Helena, Montana Site Public Contact - (mccinfo@mtcancer.org)
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Billings Clinic-Cody Cody, Wyoming Site Public Contact - (research@billingsclinic.org)
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
Brigham and Women's Hospital Boston, Massachusetts
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (mccinfo@mtcancer.org)
FMH James M Stockman Cancer Institute Frederick, Maryland
Fairbanks Memorial Hospital Fairbanks, Alaska Site Public Contact - (Veronica.Stevenson@foundationhealth.org)
Fox Chase Cancer Center Philadelphia, Pennsylvania
Fox Chase Cancer Center-Rockledge Rockledge, Pennsylvania Site Public Contact - (ctsucontact@westat.com)
Geisinger Cancer Center Dickson City Dickson City, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania Site Public Contact - (cancerresearch@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Great Falls Clinic Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Hackensack University Medical Center Hackensack, New Jersey
Hi-Line Sletten Cancer Center Havre, Montana Site Public Contact - (protocols@AllianceNCTN.org)
IU Health Methodist Hospital Indianapolis, Indiana Site Public Contact - (iutrials@iu.edu)
IU Health North Hospital Carmel, Indiana Site Public Contact - (iutrials@iu.edu)
IU Health West Hospital Avon, Indiana Site Public Contact - (iutrials@iu.edu)
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana Site Public Contact - (iutrials@iu.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Lahey Clinic Burlington, Massachusetts Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org)
Lahey Clinic Peabody Peabody, Massachusetts Site Public Contact - (lhmc-cancer-clinical-trials@lahey.org)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Loyola University Medical Center Maywood, Illinois
Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois
Mary Bird Perkins Cancer Center - Metairie Metairie, Louisiana
Mayo Clinic Hospital in Arizona Phoenix, Arizona
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester Rochester, Minnesota
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Hospital of Laramie County Cheyenne, Wyoming Site Public Contact - (protocols@AllianceNCTN.org)
Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey
Memorial Sloan Kettering Bergen Montvale, New Jersey
Memorial Sloan Kettering Cancer Center New York, New York
Memorial Sloan Kettering Commack Commack, New York
Memorial Sloan Kettering Monmouth Middletown, New Jersey
Memorial Sloan Kettering Nassau Uniondale, New York
Memorial Sloan Kettering Westchester Harrison, New York
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Ralph H Johnson VA Medical Center Charleston, South Carolina Site Public Contact - (ashley.salvo@va.gov)
Renown Regional Medical Center Reno, Nevada Site Public Contact - (Renown-CRD@renown.org)
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Sibley Memorial Hospital Washington D.C., District of Columbia Site Public Contact - (jquiver1@jhmi.edu)
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California Site Public Contact - (ucstudy@uci.edu)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California Site Public Contact - (ucstudy@uci.edu)
UF Health Cancer Institute - Gainesville Gainesville, Florida
University of Alabama at Birmingham Cancer Center Birmingham, Alabama Site Public Contact - (gingerreeves@uabmc.edu)
University of Illinois Chicago, Illinois
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Veterans Affairs New York Harbor Healthcare System-Manhattan Campus New York, New York Site Public Contact - (John.hay@va.gov)

Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

Study Contact - Participate-In-This-Study1@its.jnj.com

NCT06372964
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Inclusion Criteria:

• Able to provide consent as follows: * The Legally Authorized Representative (LAR) must provide written, informed consent. * The patient must provide written assent;
• Male or female patients 10 to 17 years of age, inclusive;
• Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
• Subject has a lifetime history of at least one manic or hypomanic episode.
• Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;
• CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;
• Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 \[elevated mood\] score ≤ 2) at Screening and Baseline.
Exclusion Criteria:

• Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes: * Attention deficit hyperactivity disorder (ADHD). If a subject is taking medications for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study.
• Intellectual disability based on Investigator opinion and DSM-5 criteria
• Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;
• Demonstrates a ≥ 25% decrease (improvement) in the CDRS-R total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline;
• In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
• At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;
• At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
• At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) on the CDRS-R; or
• The patient is considered to be an imminent danger to him/herself or others.
DRUG: Lumateperone, DRUG: Placebo
Bipolar Depression
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AP Medical Research Miami, Florida
APG Research LLC Orlando, Florida
Advanced Discovery Research Atlanta, Georgia
Advanced Research Center, Inc Anaheim, California
Advanced Research Institute of Miami Homestead, Florida
Alivation Research LLC Lincoln, Nebraska
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois
BioBehavioral Research of Austin PC Austin, Texas
Care Research Center Inc Miami, Florida
CenExeli Research LLC Atlanta, Georgia
CenExeli Research LLC 1 Savannah, Georgia
Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda. Bogotá,
Centro de Investigaciones y Proyectos en Neurociencias CIPNA Barranquilla,
Charak Center for Health and Wellness Garfield Heights, Ohio
Chopda Medicare & Research Centre Nashik,
Clinic of Neurology and Psychiatry for Children and Youth Belgrade,
Clinical Center of Vojvodina Novi Sad,
Columbus Clinical Services LLC Miami, Florida
Core Clinical Research Everett, Washington
Cutting Edge Research Group Oklahoma City, Oklahoma
Deva Institute of Healthcare And Research Pvt Ltd Varanasi,
Empresa Social del Estado Hospital Mental de Antioquia Maria Upegui HOMO Bello,
Envision Trials LLC Miami, Florida
GTL Medical and Research Group Miami, Florida
Haidar Almhana Nieding Avon Lake, Ohio
Harmonex Neuroscience Research Dothan, Alabama
Health Synergy Clinical Research West Palm Beach, Florida
HealthMed Clinical Center Inc Miami, Florida
Indiana University Indianapolis, Indiana
Inland Psychiatric Medical Group Inc Redlands, California
Institute of Mental Health Serbia Belgrade,
Kaleidoscope Clinical Research Houston, Texas
Links Clinical Trials Miami, Florida
MCB Clinical Research Centers LLC Colorado Springs, Colorado
MTP Psychiatry LLC Baltimore, Maryland
Midwest Research Group Saint Charles, Missouri
NYU Child Study Center New York, New York
Neurobehavioral Medicine Group Bloomfield Hills, Michigan
New Med Research Inc Miami Gardens, Florida
Next Level Clinical Trials, LLC West Covina, California
North Pointe Psychiatry Flower Mound, Texas
Northwest Clinical Research Center Bellevue, Washington
Ocean Blue Medical Research Center Inc. Miami, Florida
Perceptive Pharma Research Richmond, Texas
Pillar Clinical Research, LLC Little Rock, Arkansas
Psynapsis Salud Mental S.A. Pereira,
REX Clinical Trials LLC Beaumont, Texas
Ratandeep Surgical Hospital And Endoscopy Clinic Ahmedabad,
Red Oak Psychiatry Associates Houston, Texas
Revive Research Institute Elgin, Illinois
Riveldi Biomedical Research Miami Lakes, Florida
Royal Palm Clinical Research Fort Myers, Florida
SP Research, PLLC (dba Rivus Wellness & Research Institute) Oklahoma City, Oklahoma
Salveo Integrative Health Inc Lawrenceville, Georgia
Society for Psychiatric Update and Research Shanti Nursing Home Aurangabad,
Sooner Clinical Research Oklahoma City, Oklahoma
SouthGen Clinical Research LLC Miami, Florida
The Angel Medical Research Corporation Miami Gardens, Florida
The University of Texas at Austin Austin, Texas
UC Davis Health System Sacramento, California
United Research Institute Hialeah, Florida
University Clinical Center Nis Niš,
University of California San Diego Medical Center La Jolla, California
University of Cincinnati Medical Center Cincinnati, Ohio
Virginia Commonwealth University Richmond, Virginia
Vital Care Research Miami, Florida
Washington University School of Medicine Child and Adolescent Psychiatry Clinic St Louis, Missouri
Westlake America Clinic Westlake, Ohio

A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation (TRANSPIRE)

US Biogen Clinical Trial Center - clinicaltrials@biogen.com

NCT07219043
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Key
Inclusion Criteria:
* MVI (MVI ≥2), donor specific antibody (DSA)-negative that is either complement activation (C4d) negative or C4d positive (biopsy-confirmed) without T cell-mediated rejection (TCMR) per central reading, as defined by the Banff 2022 criteria. * Biopsy must be prior to randomization. * For participants who received any prior treatment for antibody-mediated rejection (AMR) or MVI, the biopsy must be performed after completing (or stopping) prior treatment. * Kidney transplant prior to Screening visit (recipients of either living or deceased donors). Key
Exclusion Criteria:
* Transplant: Blood type (ABO)-incompatible transplant. * History of multiple organ transplants including en bloc and dual kidney transplants. * Acute, rapid decline in renal function, defined as a participant likely to require renal replacement therapy within the next 30 days as determined by the Investigator. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
DRUG: Felzartamab, DRUG: Placebo
Microvascular Inflammation
Kidney Transplant, Kidney Transplant Rejection
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Alberta Health Services (AHS) - University of Alberta Hospital Edmonton, Alberta
Cedars-Sinai Medical Center Los Angeles, California
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin Bordeaux,
Centre Hospitalier Universitaire (CHU) de GreNble Alpes - Hôpital Michallon La Tronche,
Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil Toulouse,
Charite - Universitatsmedizin Berlin Berlin,
Cleveland Clinic Cleveland, Ohio
Clínica Privada Velez Sarsfield Córdoba,
Cooperman Barnabas Medical Center Livingston, New Jersey
Duke University Hospital Durham, North Carolina
Hospices Civils de Lyon - Hôpital Édouard Herriot Lyon,
Hospital Clinic de Barcelona Barcelona,
Hospital Del Mar Barcelona,
Hospital Universitario Miguel Servet Zaragoza,
Hospital Universitario Vall d'Hebron Barcelona,
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP) São Paulo,
Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto Vila São José, São José Do Rio Preto
Hospital do Rim - Fundação Oswaldo Ramos São Paulo,
Houston Methodist Hospital Houston, Texas
Institut klinicke a experimentalni mediciny (IKEM) Prague,
Instituto de Trasplante y Alta Complejidad (ITAC) Buenos Aires, Ciudad Autónoma de Buenos Aires (caba)
Keck Hispital of University of Southern California (USC) Los Angeles, California
Loma Linda University Medical Center Loma Linda, California
Mayo Clinic Rochester Rochester, Minnesota
Medical College of Wisconsin Milwaukee, Wisconsin
Medizinische Universität Wien Vienna,
Penn Medicine - Hospital of the University of Pennsylvania Philadelphia, Pennsylvania
Princess Alexandra Hospital Woolloongabba, Queensland
Providence Health Care - St. Paul's Hospital Vancouver, British Columbia
Providence St. Joseph Hospital Orange Orange, California
Sutter Health - California Pacific Medical Center San Francisco, California
The Ohio State University Columbus, Ohio
The University of Kansas Medical Center Kansas City, Kansas
Universitaetsklinikum Carl Gustav Carus Dresden Dresden,
Universitatsklinikum Hamburg-Eppendorf Hamburg,
Universitatsspital Zurich Zurich,
University of California San Fransisco (UCSF) Medical Center San Francisco, California
University of California, Los Angeles Los Angeles, California
University of Colorado Aurora, Colorado
University of Michigan Medical Center Ann Arbor, Michigan
University of Nebraska Medical Center Omaha, Nebraska
University of Texas Southwestern Medical Center Dallas, Texas
University of Washington Medical Center Seattle, Washington
Vancouver General Hospital Vancouver, British Columbia
Vanderbilt University Medical Center Nashville, Tennessee
Virginia Commonwealth University (VCU) Medical Center (Main Hospital) Hume-Lee Transplant Center Richmond, Virginia
Washington University School of Medicine St Louis, Missouri
Westmead Hospital Westmead, New South Wales

Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients

Study Contact - Participate-In-This-Study1@its.jnj.com

NCT06706674
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Inclusion Criteria:

• All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient's condition, and accompany the patient to study visits.
• Able to provide consent as follows:
• The patient's LAR must provide written, informed consent.
• When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
• Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
• Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
• ABC-I subscale score of \>18 at Screening and Baseline;
• CGI-S score \> 4 with respect to irritability associated with ASD at Screening and Baseline.
Exclusion Criteria:

• Has a primary psychiatric diagnosis other than ASD. Exceptions include:
• Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.
• Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).
• History or current diagnosis of Rett syndrome or Fragile X syndrome;
• In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or
• At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (CSSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;
• At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
• The patient is considered to be an imminent danger to themselves or others.
DRUG: Lumateperone high dose, DRUG: Lumateperone low dose, DRUG: Placebo
Irritability Associated With Autism Spectrum Disorder
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AP Medical Research Miami, Florida
APG Research LLC Orlando, Florida
Advanced Discovery Research Atlanta, Georgia
Advanced Research Institute of Miami Homestead, Florida
Advantage Clinical Trials The Bronx, New York
Alivation Research LLC Lincoln, Nebraska
Baber Research Group Naperville, Illinois
BioBehavioral Research of Austin PC Austin, Texas
Blue Medical Research Miami, Florida
California Neuroscience Research Sherman Oaks, California
Care Research Center Inc Miami, Florida
Clinical Research Center of Florida Pompano Beach, Florida
Core Clinical Research Everett, Washington
EmVenio Research at Chicago Chicago, Illinois
Future Search Trials of Dallas Dallas, Texas
GTL Medical and Research Group Miami, Florida
Louisiana State University Health Sciences Center Shreveport Shreveport, Louisiana
Medical University of South Carolina Charleston, South Carolina
NYU Child Study Center New York, New York
Nathan Kline Institute Orangeburg, New York
Neurobehavioral Medicine Group Bloomfield Hills, Michigan
New Med Research Inc Miami Gardens, Florida
North Texas Clinical Trials Fort Worth, Texas
Orlando Psychiatric Associates Orlando, Florida
Pillar Clinical Research, LLC Little Rock, Arkansas
Quest Therapeutics of Avon Lake Avon Lake, Ohio
Red Oak Psychiatry Associates Houston, Texas
Richmond Behavioral Associates Staten Island, New York
Riley Hospital for Children at Indiana University Health Indianapolis, Indiana
Riveldi Biomedical Research Miami Lakes, Florida
SP Research, PLLC (dba Rivus Wellness & Research Institute) Oklahoma City, Oklahoma
Salveo Integrative Health Inc Lawrenceville, Georgia
Sooner Clinical Research Oklahoma City, Oklahoma
Texas Research Group Coppell, Texas
United Research Institute Hialeah, Florida
University of California - Davis Sacramento, California
University of South Florida Rothman Center of Neuropsychiatry St. Petersburg, Florida
Virginia Commonwealth University Richmond, Virginia
Vital Care Research Miami, Florida
Yale University School of Medicine New Haven, Connecticut

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

Study Contact - Participate-In-This-Study1@its.jnj.com

NCT06229210
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Inclusion Criteria:
* Able to provide consent as follows: * The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent; * The patient must provide written assent to study enrollment; * Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder; * Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL). * Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study. Rollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator.
Exclusion Criteria:
* Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include: * ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records. * For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed. Severe or profound intellectual disability is exclusionary. * In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or * At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit; * At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or * At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) of the CDRS-R (for bipolar disorder patients only); or * The patient is considered to be an imminent danger to him/herself or others.
DRUG: Lumateperone
Schizophrenia, Bipolar Disorder, Autism Spectrum Disorder
Pediatric
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AIM Trials Plano, Texas
AP Medical Research Miami, Florida
APG Research LLC Orlando, Florida
Access Clinical Trials Nashville, Tennessee
Advanced Research Center, Inc Anaheim, California
Advanced Research Institute of Miami Homestead, Florida
Alivation Research LLC Lincoln, Nebraska
Atlanta Behavioral Research, LLC Atlanta, Georgia
Atlanta Center for Medical Research Atlanta, Georgia
Baber Research Group Naperville, Illinois
Blue Medical Research Miami, Florida
Care Research Center Inc Miami, Florida
CenExeli Research LLC Atlanta, Georgia
CenExeli Research LLC 1 Savannah, Georgia
Centro de Investigaciones y Proyectos en Neurociencias CIPNA Barranquilla,
Charak Center for Health and Wellness Garfield Heights, Ohio
Clinic of Neurology and Psychiatry for Children and Youth Belgrade,
Clinical Center of Vojvodina Novi Sad,
Clinical Research Center of Florida Pompano Beach, Florida
Clinical Research of Southern Nevada, LLC Las Vegas, Nevada
Columbus Clinical Services LLC Miami, Florida
Core Clinical Research Everett, Washington
Cutting Edge Research Group Oklahoma City, Oklahoma
Diverse Clinical Research LLC Miami, Florida
Envision Trials LLC Miami, Florida
Excell Research Inc Oceanside, California
GTL Medical and Research Group Miami, Florida
Green Leaf Clinical Trials Jacksonville, Florida
HOMO - ESE Hospital Mental de Antioquia Bello,
Health Synergy Clinical Research West Palm Beach, Florida
Inland Psychiatric Medical Group Inc Redlands, California
Institute of Mental Health Serbia Belgrade,
Kaleidoscope Clinical Research Houston, Texas
Links Clinical Trials Miami, Florida
MCB Clinical Research Centers LLC Colorado Springs, Colorado
Midwest Research Group 1 Saint Charles, Missouri
NYU Child Study Center New York, New York
National Institute Of Clinical Research Garden Grove, California
Neurobehavioral Medicine Group Bloomfield Hills, Michigan
New Med Research Inc Miami Gardens, Florida
Next Level Clinical Trials, LLC West Covina, California
Northwest Clinical Research Center Bellevue, Washington
Perceptive Pharma Research Richmond, Texas
Pillar Clinical Research, LLC Little Rock, Arkansas
PsyMed Solutions Fort Worth, Texas
Quest Therapeutics of Avon Lake Avon Lake, Ohio
Red Oak Psychiatry Associates Houston, Texas
Richmond Behavioral Associates Staten Island, New York
Riley Hospital for Children at Indiana University Health Indianapolis, Indiana
Riveldi Biomedical Research Miami Lakes, Florida
Royal Palm Clinical Research Fort Myers, Florida
Salveo Integrative Health Inc Lawrenceville, Georgia
Sarkis Clinical Trials Gainesville, Florida
Sooner Clinical Research Oklahoma City, Oklahoma
Southwest Autism Research and Resource Center Phoenix, Arizona
Texas Research Group Coppell, Texas
The Angel Medical Research Corporation Miami Gardens, Florida
United Research Institute Hialeah, Florida
University Clinical Center Nis Niš,
University of California - Davis Sacramento, California
University of California San Diego La Jolla, California
University of Cincinnati Medical Center Cincinnati, Ohio
University of South Florida Rothman Center of Neuropsychiatry St. Petersburg, Florida
Virginia Commonwealth University Richmond, Virginia
Vital Care Research Miami, Florida

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

Boehringer Ingelheim - clintriage.rdg@boehringer-ingelheim.com

NCT06632444
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Inclusion criteria:
• Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent
• Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \[NAS\] ≥4
• Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used
• Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply Exclusion criteria:
• Any of the following liver laboratory test abnormalities at screening: * Serum AST and/or alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN) * Platelet count \<140 000/mm\^3 (\<140 GI/L) * Alkaline phosphatase \>2x upper limit of normal (ULN) * Abnormal synthetic liver function as defined by screening central laboratory evaluation: * Albumin below \<3.5 g/dL (35.0 g/L) * OR International normalised ratio (INR) of prothrombin time \>1.3 * OR total serum bilirubin concentration ≥1.5x ULN
• Any history or evidence of acute or chronic liver disease other than MASH
• Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy
• History of or current diagnosis of hepatocellular carcinoma
• History of or planned liver transplant
• Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.
• History of portal hypertension or presence of decompensated liver disease
• Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply
COMBINATION_PRODUCT: Survodutide, COMBINATION_PRODUCT: Placebo
Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis
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310 Clinical Research Inglewood, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ASHA Clinical Research - Munster, LLC Hammond, Indiana Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
AZ Delta Roeselare, Boehringer Ingelheim - (belgique@bitrialsupport.com)
Aberdeen Royal Infirmary Aberdeen, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Accellacare - South London Orpington, London, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Accellacare North London Northwood, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Access research Institute Brooksville, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Acclaim Clinical Research San Diego, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Acibadem City Clinic Tokuda University Hospital EAD Sofia, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Adobe Clinical Research, Llc Tucson, Arizona Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Albert SchweitzerZiekenhuis Dordrecht, Boehringer Ingelheim - (nederland@bitrialsupport.com)
All India Institute of Medical Sciences New Delhi, Boehringer Ingelheim - (india@bitrialsupport.com)
American Research Corporation - Austin Austin, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
American Research Corporation at the Texas Liver Institute San Antonio, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Amsterdam UMC Locatie VUMC Amsterdam, Boehringer Ingelheim - (nederland@bitrialsupport.com)
Ankara Üniversitesi Tıp Fakültesi Hastanesi Ankara, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Arensia Clinics S.R.L. Bucharest, Boehringer Ingelheim - (romania@bitrialsupport.com)
Arizona Liver Health - Tucson Tucson, Arizona Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ark Clinical Research Long Beach, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ark Clinical Research Long Beach, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Aryav Superspeciality Hospital Ahemdabad, Boehringer Ingelheim - (india@bitrialsupport.com)
Asan Medical Center Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Asfendiyarov Kazakh National Medical University Almaty, Boehringer Ingelheim - (kazakhstan@bitrialsupport.com)
Atharva Multispecialty Hospital and research Centre Lucknow, Boehringer Ingelheim - (india@bitrialsupport.com)
Austin Health Heidelberg, Victoria Boehringer Ingelheim - (australia@bitrialsupport.com)
Az.Osp. Universitaria "Ospedali Riuniti" Foggia, Boehringer Ingelheim - (italia@bitrialsupport.com)
Azienda Ospedaliera Universitaria Integrata Verona Verona, Boehringer Ingelheim - (italia@bitrialsupport.com)
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo, Boehringer Ingelheim - (italia@bitrialsupport.com)
BAPS Pramukh Swami Hospital Surat, Boehringer Ingelheim - (india@bitrialsupport.com)
Basil Clinical Laurelton, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Beijing Ditan Hospital Capital Medical University Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Beijing Friendship Hospital Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Beijing Tsinghua Changgung Hospital Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Beijing Youan Hospital, Capital Medical University Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Bellaire Clinical Research, LLC Bellaire, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ben Taub General Hospital Houston, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi Fatih, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
BioMed Research & Medical Center Miami, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Biopharma Informatic LLC McAllen, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Biopharma Informatic, Inc. Research Center Houston, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Bodyclinic sp. z o.o. sp.k. Warsaw, Boehringer Ingelheim - (polska@bitrialsupport.com)
Boston Medical Center Boston, Massachusetts Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Brooke Army Medical Center San Antonio, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Buenos Aires Macula S.A. Buenos Aires, Boehringer Ingelheim - (argentina@bitrialsupport.com)
CHU Amiens-Picardie Amiens, Boehringer Ingelheim - (france@bitrialsupport.com)
CIPREC Buenos Aires, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Cadena Care Institute, LLC Poway, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
California Liver Research Institute Pasadena, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Care United Research Forney, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Carolina Researche Greenville, North Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Catalina Research Institute, Llc Montclair, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Cenara Clinical Research Cutler Bay, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Centex Studies, Inc. McAllen, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Centre Hospitalier Lyon Sud Pierre-Bénite, Boehringer Ingelheim - (france@bitrialsupport.com)
Centre Hospitalier Universitaire d'Angers Angers, Boehringer Ingelheim - (france@bitrialsupport.com)
Centre Hospitalier Universitaire de Bordeaux Pessac, Boehringer Ingelheim - (france@bitrialsupport.com)
Centre Hospitalier Universitaire de Liege Liège, Boehringer Ingelheim - (belgique@bitrialsupport.com)
Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec Boehringer Ingelheim - (canada@bitrialsupport.com)
Centre Hospitalier de Versailles Le Chesnay, Boehringer Ingelheim - (france@bitrialsupport.com)
Centre de Médecine Métabolique de Lanaudière Terrebonne, Quebec Boehringer Ingelheim - (canada@bitrialsupport.com)
Centricity Research (New Bern) New Bern, North Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Centro De Investigaciones Clínicas Viña Del Mar Viña del Mar, Boehringer Ingelheim - (chile@bitrialsupport.com)
Centro de Alta Especialidad del Estado de Veracruz Xalapa, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Centro de Investigacion Clinica del Pacifico (CICPA) Acapulco de Juárez, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Centro de Investigacion y Gastroenterologia Mexico City, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Centro de Investigacion y Gastroenterologia Mexico City, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Centro de Investigaciones Metabólicas (CINME) Buenos Aires, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Centro de Investigaciones Médicas UC Santiago, Boehringer Ingelheim - (chile@bitrialsupport.com)
Centro de Pesquisa Clinica do Brasil Lago Sul, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Chang Gung Medical Foundation (CGMF) - Linkou Bran Taoyuan, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Changhua Christian Hospital Changhua, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Changi General Hospital Singapore, Boehringer Ingelheim - (singapore@bitrialsupport.com)
Changzhou Third People's Hospital Changzhou Shi, Boehringer Ingelheim - (china@bitrialsupport.com)
Charite - Universitatsmedizin Berlin Berlin, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Charlotte Maxeke Johannesburg Academic Hospital Johannesburg, Boehringer Ingelheim - (southafrica@bitrialsupport.com)
Charter Research The Villages, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Charter Research The Villages, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Chelsea and Westminster Hospital London, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Chi Mei Medical Center Tainan, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Chiba University Hospital Chiba, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Chongqing Three Gorges Central Hospital Chongqing, Boehringer Ingelheim - (china@bitrialsupport.com)
Christchurch Hospital Christchurch, Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Chung Shan Medical University Hospital Taichung, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Chung-Ang University Hospital Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
ClinSearch, LLC Chattanooga, Tennessee Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinical Research Institute of Michigan, LLC Clinton Township, Michigan Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinical Research Professionals Chesterfield, Missouri Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinical Research of South Nevada Las Vegas, Nevada Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinical Trials of Texas, LLC San Antonio, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinicos Asociados BOCM SC Mexico City, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Clinique Saint-Luc Bouge Namur, Boehringer Ingelheim - (belgique@bitrialsupport.com)
Cliniques Universitaires Saint-Luc Brussels, Boehringer Ingelheim - (belgique@bitrialsupport.com)
Clinnova Research Solutions Orange, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Cluj Napoca Clinical County Hospital Cluj-Napoca, Boehringer Ingelheim - (romania@bitrialsupport.com)
Coastal Research Institute, LLC Fayetteville, North Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Complejo Hospitalario Universitario A Coruna A Coruña, Boehringer Ingelheim - (espana@bitrialsupport.com)
Complexo Hospitalario Universitario de Pontevedra Pontevedra, Boehringer Ingelheim - (espana@bitrialsupport.com)
Concord Repatriation General Hospital Concord, New South Wales
Connecticut Gastroenterology Clinical Research Foundation Bristol, Connecticut Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Conquest Research Winter Park, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Covenant Metabolic Specialist, LLC - Riverview Riverview, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Covenant Metabolic Specialists, LLC - Fort Myers Fort Myers, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Covenant Metabolic Specialists, LLC - University Park University Park, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
DIM Clinica Privada Ramos Mejía, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Del Sol Research Management, LLC Tucson, Arizona Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet Budapest, Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
Delta Research Partners, LLC Bastrop, Louisiana Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Diagnostic Consultative Center Alexandrovska Sofia, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Diex Recherche Quebec Québec, Boehringer Ingelheim - (canada@bitrialsupport.com)
Digestive Research Alliance of Michiana South Bend, Indiana Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Dr. Rethy Pal Hospital Békéscsaba, Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
Duke University Medical Center Durham, North Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
E-DA Hospital Kaohsiung City, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
ECIR Miami Holdings LLC dba IMIC Miami, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
EMC Instytut Medyczny S.A. - Wroclaw Wroclaw, Boehringer Ingelheim - (polska@bitrialsupport.com)
EUGASTRO GmbH Leipzig, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Edificio Fleming La Serena, Boehringer Ingelheim - (chile@bitrialsupport.com)
Ege Universitesi Tip Fakultesi Izmir, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Ehime University Hospital Ehime, Toon, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Elpida Clinical Trials - Ashton Clinic Ashton in Makerfield, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Elpida Clinical Trials - Edgware Community Hospital Edgware, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Elpida Clinical Trials - Parsloes Hub Dagenham, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
EmVenio Research Center at Prime Healthcare - Farmers Branch Garden City, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
EmVenio Research Center at Prime Healthcare - Riverdale Riverdale, Georgia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Endoscopic Research, Inc Orlando, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Entrust Clinical Research Miami, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Epic Clinical Research Lewisville, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Epic Medical Research - Carrollton Carrollton, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Epic Medical Research - DeSoto DeSoto, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Epic Medical Research - Garland Garland, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Epic Medical Research - Plano Plano, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Erasmus Medisch Centrum Rotterdam, Boehringer Ingelheim - (nederland@bitrialsupport.com)
Evolution Clinical Trials Hialeah Gardens, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Excel Clinical Research Las Vegas, Nevada Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
FDI Clinical Research San Juan, Boehringer Ingelheim - (support@bitrialsupport.com)
FOMAT Medical Research Oxnard, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ficramed Research Institute Poway, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
First Affiliated Hospital of Xi'an JiaoTong University Xi'an, Boehringer Ingelheim - (china@bitrialsupport.com)
Florida Medical Clinic, P.A. Zephyrhills, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Florida Research Institute Lakewood Rch, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Floridian Clinical Research Miami Lakes, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Fondazione Epatocentro Ticino Arzo, Boehringer Ingelheim - (suisse@bitrialsupport.com)
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico Milan, Boehringer Ingelheim - (italia@bitrialsupport.com)
Fondazione Policlinico Universitario Agostino Gemelli Irccs Rome, Boehringer Ingelheim - (italia@bitrialsupport.com)
Fondazione Policlinico Universitario Campus Bio-Medico Rome, Boehringer Ingelheim - (italia@bitrialsupport.com)
Fortis Hospital, Mohali Mohali, Boehringer Ingelheim - (india@bitrialsupport.com)
Franciscus Gasthuis Schiedam, Boehringer Ingelheim - (nederland@bitrialsupport.com)
Fresno Clinical Research Center Fresno, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Frimley Park Hospital Camberley, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Fujita Health University Hospital Toyoake, Aichi-ken Boehringer Ingelheim - (nippon@bitrialsupport.com)
Fukuiken Saiseikai Hospital Fukui-shi, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Future Innovative Treatments Colorado Springs, Colorado Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
FutureMeds Lodz Lodz, Boehringer Ingelheim - (polska@bitrialsupport.com)
FutureMeds Warszawa Centrum Warsaw, Boehringer Ingelheim - (polska@bitrialsupport.com)
FutureMeds Wroclaw Wroclaw, Boehringer Ingelheim - (polska@bitrialsupport.com)
GI Alliance Research - Dallas Dallas, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
GI Alliance Research - Mansfield Mansfield, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
GI PROS Research Naples, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
GI Select Health Research, LLC Richmond, Virginia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Gastroenterology Associates of Central Georgia Macon, Georgia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Gastrointestinal Associates, PA Flowood, Mississippi Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Gastromedica Srl Iași, Boehringer Ingelheim - (romania@bitrialsupport.com)
Gazi Universitesi Tip Fakultesi Ankara, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Geisinger Health State College, Pennsylvania Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
General Hospital of Ningxia Medical University Ningxia, Boehringer Ingelheim - (china@bitrialsupport.com)
Gifu Municipal Hospital Gifu, Gifu, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Glenny Corp - Centro Médico Saavedra Buenos Aires, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Global Clinical Professionals St. Petersburg, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Global Research Associates Homestead, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Great Lakes Gastroenterology Mentor, Ohio Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Guangzhou Eighth People's Hospital,Guangzhou Medical University Guangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Guangzhou First People's Hospital Guangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Guizhou Provincial People's Hospital Guiyang, Boehringer Ingelheim - (china@bitrialsupport.com)
Gujarat Gastro and Vascular Hospital Surat, Boehringer Ingelheim - (india@bitrialsupport.com)
HASresearch San Antonio, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
HOP Dijon-Bourgogne Dijon, Boehringer Ingelheim - (france@bitrialsupport.com)
HRI Medical Center Houston, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Hamamatsu University Hospital Shizuoka, Hamamatsu, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hi Tech and Global Research, LLC Coral Gables, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital Hiroshima, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hiroshima University Hospital Hiroshima, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hope Clinical Research Canoga Park, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Hopital Beaujon Clichy, Boehringer Ingelheim - (france@bitrialsupport.com)
Hopital Claude Huriez Lille, Boehringer Ingelheim - (france@bitrialsupport.com)
Hopital Cochin Paris, Boehringer Ingelheim - (france@bitrialsupport.com)
Hopital Henri Mondor Créteil, Boehringer Ingelheim - (france@bitrialsupport.com)
Hopital de la Croix-Rousse Lyon, Boehringer Ingelheim - (france@bitrialsupport.com)
Hopitaux Universitaires Pitié-Salpétrière Paris, Boehringer Ingelheim - (france@bitrialsupport.com)
Hopitaux Universitaires de Geneve (HUG) Geneva, Boehringer Ingelheim - (suisse@bitrialsupport.com)
Hospital Ampang Ampang, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Hospital Clinico de Santiago Santiago de Compostela, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Das Clinicas Da Faculdade De Medicina Da USP Cerqueira César, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Hospital El Cruce San Juan Bautista, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Hospital General de Agudos Dr. J. M. Ramos Mejia Ciudad Autonoma Buenos Aires, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Hospital Puerta De Hierro Majadahonda, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitari Vall d'Hebron Barcelona, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario 12 de Octubre Madrid, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario Austral Pilar, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Hospital Universitario Joao de Barros Barreto Belém, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Hospital Universitario Marqués de Valdecilla Santander, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario Reina Sofia Córdoba, Andalusia Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universiti Sains Malaysia Kota Bharu, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Hospital das Clinicas da Universidade Federal de Minas Gerais (HC-UFMG) Belo Horizonte, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Hospital de Base São José do Rio Preto, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Hospitalar Moinhos de Vento Porto Alegre, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Huashan Hospital, Fudan University Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Hull Royal Infirmary Hull, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Hunan Provincial People's Hospital Changsha, Boehringer Ingelheim - (china@bitrialsupport.com)
Hyogo College of Medicine Hospital Hyogo, Nishinomiya, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hôpital Erasme Brussels, Boehringer Ingelheim - (belgique@bitrialsupport.com)
Hôpital Rangueil - CHU de Toulouse Toulouse, Boehringer Ingelheim - (france@bitrialsupport.com)
Hôpital de l'Archet Nice, Boehringer Ingelheim - (france@bitrialsupport.com)
ID Clinic Mysłowice, Boehringer Ingelheim - (polska@bitrialsupport.com)
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas Buenos Aires, Boehringer Ingelheim - (argentina@bitrialsupport.com)
IMA Clinical Research Austin Austin, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
IMA Clinical Research-Warren-69742 Warren Township, New Jersey Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
IRCCS Ospedale "Casa Sollievo della Sofferenza" San Giovanni Rotondo, Boehringer Ingelheim - (italia@bitrialsupport.com)
Icahn School of Medicine at Mount Sinai New York, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Inha University Hospital Incheon, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Inland Empire Clinical Trials, LLC Rialto, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Innovation Medical Research Center Palmetto Bay, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Innovative Clinical Research Clarksville, Tennessee Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Insitute of Liver and Billiary Sciences New Delhi, Boehringer Ingelheim - (india@bitrialsupport.com)
Inspired GI Care Plumstead, Boehringer Ingelheim - (southafrica@bitrialsupport.com)
Institute of Gastroenterology, Hepatology and Metabolism LLP Almaty, Boehringer Ingelheim - (kazakhstan@bitrialsupport.com)
Institute of Science Tokyo Hospital Tokyo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Instituto de Diabetes, Obesidad y Nutrición S.C. Cuernavaca, Boehringer Ingelheim - (mexico@bitrialsupport.com)
International Center for Research Tampa, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
International University of Health and Welfare Narita Hospital Narita, Chiba Boehringer Ingelheim - (nippon@bitrialsupport.com)
Iowa Diabetes and Endocrinology Research Center West Des Moines, Iowa Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Iowa Digestive Disease Center Clive, Iowa Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Irbid Specialty Hospital Irbid, Boehringer Ingelheim - (support@bitrialsupport.com)
Israeli - Georgian Medical Research Clinic Healthycore LTD Tbilisi, Boehringer Ingelheim - (sakartvelo@bitrialsupport.com)
Istituto Clinico Humanitas Rozzano, Boehringer Ingelheim - (italia@bitrialsupport.com)
Iwate Medical University Hospital Shiwa-gun, Boehringer Ingelheim - (nippon@bitrialsupport.com)
JCHO Shimonoseki Medical Center Shimonoseki, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Japan Community Health Care Organization Hokkaido Hospital Hokkaido, Sapporo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Japan Institute for Health Security National Kohnodai Medical Center Chiba, Ichikawa, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Japanese Red Cross Musashino Hospital Musashino, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Jordan University Hospital Jordan, Boehringer Ingelheim - (support@bitrialsupport.com)
Jubilee Clinical Research, Inc Las Vegas, Nevada Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Juntendo University Shizuoka Hospital Shizuoka, Izunokuni, Boehringer Ingelheim - (nippon@bitrialsupport.com)
K2 Medical Research Orlando, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
K2 Medical Research Orlando, Florida
K2 Medical Research - Winter Garden Clermont, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Kagawa University Hospital Kita-gun, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kagoshima University Hospital Kagoshima, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kanazawa University Hospital Ishikawa, Kanazawa, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kansas City Research Institute Kansas City, Missouri Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Kansas Medical Clinic PA Topeka, Kansas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
King Abdulaziz Medical City, National Guard Health Affairs Riyadh, Boehringer Ingelheim - (saudi@bitrialsupport.com)
King Faisal Specialist Hospital and Research Center Riyadh, Boehringer Ingelheim - (saudi@bitrialsupport.com)
King's College Hospital London, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Klinical Investigations Group, LLC San Juan, Boehringer Ingelheim - (support@bitrialsupport.com)
Klinik Hietzing Vienna, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Klinik Landstraße Vienna, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Klinikum Landshut AdöR der Stadt Landshut Landshut, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Klinikum Wels - Grieskirchen GmbH Wels, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Kobe University Hospital Kobe, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Koc Universitesi Hastanesi Istanbul, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Korea University Guro Hospital Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Krajska Nemocnice Liberec a.s. Liberec, Boehringer Ingelheim - (support@bitrialsupport.com)
Kumamoto Shinto General Hospital Kumamoto, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kumamoto University Hospital Kumamoto, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kurume University Hospital Fukuoka, Kurume, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Lake Center for Clinical Research Lady Lake, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Latin Clinical Trial Center San Juan, Boehringer Ingelheim - (support@bitrialsupport.com)
Lenasia Clinical Trial Centre Johannesburg, Boehringer Ingelheim - (southafrica@bitrialsupport.com)
Liaocheng People's Hospital Liaocheng, Boehringer Ingelheim - (china@bitrialsupport.com)
Liver Institute of Virginia-Bremo Newport News, Virginia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Liverpool Hospital Liverpool, New South Wales Boehringer Ingelheim - (australia@bitrialsupport.com)
Louisiana Research Center, LLC Shreveport, Louisiana Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ltd "Health" Batumi, Boehringer Ingelheim - (sakartvelo@bitrialsupport.com)
M3 Wake Research, Inc. Raleigh, North Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
MHAT Sv. Ivan Rilski EOOD Gorna Oryahovitsa, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
MNGI Digestive Health, PA Minneapolis, Minnesota Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ManglamPlus Medicity Hospital Jaipur, Boehringer Ingelheim - (india@bitrialsupport.com)
Mautalen- Salud e Investigacion Buenos Aires, Boehringer Ingelheim - (argentina@bitrialsupport.com)
McGill University Health Centre (MUHC) Montreal, Quebec Boehringer Ingelheim - (canada@bitrialsupport.com)
Medical Associates Research Group, Inc. San Diego, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Medical Care and Research Mérida, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Medical Center New Rehabilitation Center EOOD Stara Zagora, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Medical Centre FutureMeds Krakow Krakow, Boehringer Ingelheim - (polska@bitrialsupport.com)
Medical Military Academy MHAT Sofia Sofia, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Medical University of Graz Graz, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Medical University of South Carolina Charleston, South Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Medical University of Vienna Vienna, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Memorial Bahçelievler Hospital Istanbul, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Mengchao Hepatobiliary Hospital of Fujian Medical University Fuzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Mercy Medical Center Springfield, Massachusetts Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Metro Clinical Trials San Bernardino, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Midas Multispeciality Hospital Pvt. Ltd. Nagpur, Boehringer Ingelheim - (india@bitrialsupport.com)
Middlemore Hospital Papatoetoe, Auckland Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Mie University Hospital Tsu, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Monash Health Clayton, Victoria Boehringer Ingelheim - (australia@bitrialsupport.com)
MplusM - Best Choice Medical and Research Service Pembroke Pines, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Multi-profile Hospital For Active Treatment-Uni Hospital Ltd. Panagyurishte, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Nagano Municipal Hospital Hanishina-gun, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Nagasaki Medical Center Nagasaki, Omura, Boehringer Ingelheim - (nippon@bitrialsupport.com)
NanFang Hosptial Guangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Nanjing Drum Tower Hospital Nanjing, Boehringer Ingelheim - (china@bitrialsupport.com)
Nara Medical University Hospital Nara, Kashihara, Boehringer Ingelheim - (nippon@bitrialsupport.com)
National Cheng Kung University Hospital Tainan, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
National Hospital Organization Kure Medical Center and Chugoku Cancer Center Kure, Boehringer Ingelheim - (nippon@bitrialsupport.com)
National Hospital Organization Kyushu Medical Center Fukuoka, Boehringer Ingelheim - (nippon@bitrialsupport.com)
National Hospital Organization Takasaki General Medical Center Takasaki-shi, Boehringer Ingelheim - (nippon@bitrialsupport.com)
National Taiwan University Hospital Taipei, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
National University Hospital Singapore, Boehringer Ingelheim - (singapore@bitrialsupport.com)
Neoclinical Research Hialeah, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Nepean Hospital Kingswood, New South Wales Boehringer Ingelheim - (australia@bitrialsupport.com)
New Zealand Clinical Research (NZCR) Grafton, Auckland Boehringer Ingelheim - (newzealand@bitrialsupport.com)
NewYork-Presbyterian Brooklyn Methodist Hospital Brooklyn, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Newcastle General Hospital Newcastle upon Tyne, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Nihon University Itabashi Hospital Tokyo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Niigata University Medical and Dental Hospital Niigata, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Ningbo Second Hospital Ningbo, Boehringer Ingelheim - (china@bitrialsupport.com)
Nippon Medical School Hospital Tokyo, Bunkyo-ku, Boehringer Ingelheim - (nippon@bitrialsupport.com)
North Texas Research Institute - Dallas Dallas, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Northshore Gastroenterology Research Westlake, Ohio Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
OMEGA Research Group Altamonte Springs, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Objective Health-Digestive Research of Central Texas Waco, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ObjectiveHealth-Columbia Digestive Health Research Columbia, South Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ObjectiveHealth-DSI Research - Springboro, LLC Springboro, Ohio Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ObjectiveHealth-Digestive Health Research of North Texas Wichita Falls, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ObjectiveHealth-GI Associates Research Columbia, Missouri Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Obudai Egeszegugyi Centrum Budapest, Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
Oita Cardiovascular Hospital Ōita, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Okayama University Hospital Okayama, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Om Research, LLC Victorville, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Om Research, LLC Victorville, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Optimus U Corporation-Miami-69452 Miami, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Options Health Research Tulsa, Oklahoma Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ordensklinikum Linz GmbH Linz, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Osaka City University Hospital Osaka, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Osaka Rosai Hospital Sakai, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Osmania Medical College & Hospital Hyderabad, Afzalgunj, Boehringer Ingelheim - (india@bitrialsupport.com)
Ospedale Maggiore Della Carita Novara, Boehringer Ingelheim - (italia@bitrialsupport.com)
Otto-von-Guericke-Universitat Magdeburg Magdeburg, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Pacific Gastroenterology Associates Vancouver, British Columbia Boehringer Ingelheim - (canada@bitrialsupport.com)
Palmetto Clinical Research Summerville, South Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak, Boehringer Ingelheim - (india@bitrialsupport.com)
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Peking University People's Hospital Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
PingXiang People's Hospital Pingxiang, Boehringer Ingelheim - (china@bitrialsupport.com)
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Post Graduate Institute of Medical Education and Research Chandigarh, Boehringer Ingelheim - (india@bitrialsupport.com)
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Progressive Medical Research Port Orange, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pusan National University Hospital Busan, Boehringer Ingelheim - (namhan@bitrialsupport.com)
QingDao Municipal Hospital Qingdao, Boehringer Ingelheim - (china@bitrialsupport.com)
Queen Elizabeth Hospital Putrajaya, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
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Queen's Medical Centre Nottingham, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Radboud Universitair Medisch Centrum Nijmegen, Boehringer Ingelheim - (nederland@bitrialsupport.com)
Recep Tayyip Erdogan Universitesi Egitim ve Arastirma Hastanesi Rize, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Regional Institute of Gastroenterology Hepatology "Prof. Dr. O. Fodor" Cluj-Napoca, Boehringer Ingelheim - (romania@bitrialsupport.com)
Renji Hospital Shanghai Jiaotong University School of Medicine Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Renmin Hospital of Wuhan University Wuhan, Boehringer Ingelheim - (china@bitrialsupport.com)
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Royal Melbourne Hospital Parkville, Victoria Boehringer Ingelheim - (australia@bitrialsupport.com)
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Schiff Center Liver Diseases Miami, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Scottsdale Medical Specialists, Ltd Scottsdale, Arizona Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Second Affiliated Hospital of medical college of Xi'an JiaoTong University Xi'an, Boehringer Ingelheim - (china@bitrialsupport.com)
Seichokai Bell Land General Hospital Sakai, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Semmelweis Egyetem Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika Budapest, Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
Sendai Tokushukai Hospital Sendai, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Seoul National University Hospital Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Shanghai East Hospital Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Shanghai General Hospital Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Shanghai Public Health Clinical Center Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Shimane University Hospital Izumo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Shin-Yurigaoka General Hospital Kanagawa, Kawasaki, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Shinshu University Hospital Nagano, Matsumoto, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Singapore General Hospital Singapore, Boehringer Ingelheim - (singapore@bitrialsupport.com)
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Sixth People's Hospital of Zhengzhou Zhengzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Soma Clinical Trials Denison, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Soon Chun Hyang University Hospital Bucheon Bucheon-si, Boehringer Ingelheim - (namhan@bitrialsupport.com)
South Denver Gastroenterology PC Englewood, Colorado Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
South Texas Research Institute - Brownsville Brownsville, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
South Texas Research Institute-Edinburg-67012 Edinburg, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Southampton General Hospital Southampton, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Southern California Research Center Coronado, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Spital Judetean De Urgenta Satu Mare Satu Mare, Boehringer Ingelheim - (romania@bitrialsupport.com)
Spitalul Clinic Judetean De Urgenta Craiova Craiova, Boehringer Ingelheim - (romania@bitrialsupport.com)
St George's Hospital Tooting, London, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
St. Josefs-Hospital Wiesbaden Wiesbaden, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
St. Marianna University Hospital Kawasaki-shi, Boehringer Ingelheim - (nippon@bitrialsupport.com)
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Sunshine Coast University Hospital Birtinya, Queensland Boehringer Ingelheim - (australia@bitrialsupport.com)
Surat Institute of Digestive Sciences Surat, Boehringer Ingelheim - (india@bitrialsupport.com)
Synergy Healthcare Bradenton, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
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Taichung Veterans General Hospital Taichung, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Taipei Medical University Hospital Taipei, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Taipei Veterans General Hospital Taipei, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
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Technische Universitat Dresden Dresden, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Texas Clinical Research Institute, LLC Arlington, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
The Affiliated Hospital of Hangzhou Normal University Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
The Affiliated Hospital of Xuzhou Medical College Xuzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
The Fifth People's Hospital of Suzhou Suzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of Henan University of Science and Technology Luoyang, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of NanChang University Nanchang, Boehringer Ingelheim - (china@bitrialsupport.com)
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The First Affiliated Hospital, Zhejiang University Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital,Sun Yat-sen University Guangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
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The First Hospital of Jiaxing Jiaxing, Boehringer Ingelheim - (china@bitrialsupport.com)
The First People's Hospital of Foshan Foshan, Boehringer Ingelheim - (china@bitrialsupport.com)
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The Ohio State University Wexner Medical Center Columbus, Ohio Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
The Second Affiliated Hospital to Nanchang University Nanchang, Boehringer Ingelheim - (china@bitrialsupport.com)
The Second Hospital of Nanjing Nanjing, Boehringer Ingelheim - (china@bitrialsupport.com)
The Sixth People's Hospital of Shenyang Shenyang, Boehringer Ingelheim - (china@bitrialsupport.com)
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The Third People's Hospital of Zhenjiang Zhenjiang, Boehringer Ingelheim - (china@bitrialsupport.com)
The University of Osaka Hospital Suita-shi, Boehringer Ingelheim - (nippon@bitrialsupport.com)
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The third affiliated hospital of Sun Yat-Sen University Guangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Tianjin Second People's Hospital Tianjin, Boehringer Ingelheim - (china@bitrialsupport.com)
Tianjin Third Central Hospital Tianjin, Boehringer Ingelheim - (china@bitrialsupport.com)
Tokai University Hospital Isehara-shi, Boehringer Ingelheim - (nippon@bitrialsupport.com)
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Tokyo Medical University Ibaraki Medical Center Ibaraki, Inashiki-gun, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Toranomon Hospital Tokyo, Minato-ku, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Toronto Liver Centre Toronto, Ontario Boehringer Ingelheim - (canada@bitrialsupport.com)
Tweesteden Ziekenhuis, locatie Tilburg Tilburg, Boehringer Ingelheim - (nederland@bitrialsupport.com)
US Digestive Health Wyomissing, Pennsylvania Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
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Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan, Boehringer Ingelheim - (china@bitrialsupport.com)
Universidade Estadual Paulista "Julio De Mesquita Filho" Botucatu, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Universidade Federal do Rio Grande do Sul Porto Alegre, Boehringer Ingelheim - (brasil@bitrialsupport.com)
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University Hospital Kyoto Prefectural University of Medicine Kyoto, Boehringer Ingelheim - (nippon@bitrialsupport.com)
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University Malaya Medical Centre Kuala Lumpur, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
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University of Rochester Medical Center Rochester, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
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VCU Medical Center West Hospital Richmond, Virginia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
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Vseobecna Fakultni Nemocnice v Praze Prague, Boehringer Ingelheim - (support@bitrialsupport.com)
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Wuxi No. 5 People's Hospital Wuxi, Boehringer Ingelheim - (china@bitrialsupport.com)
Xiangya Hospital, Central South University Changsha, Boehringer Ingelheim - (china@bitrialsupport.com)
Yale University School of Medicine New Haven, Connecticut Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
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Yashoda Hospitals - Secunderabad Secunderabad, Boehringer Ingelheim - (india@bitrialsupport.com)
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Yonsei University Wonju Severance Christian Hospital Wŏnju, Boehringer Ingelheim - (namhan@bitrialsupport.com)
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Yuncheng Center Hopsital Yuncheng, Boehringer Ingelheim - (china@bitrialsupport.com)
Zenos Clinical Research Dallas, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Zhejiang Hospital Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Ziekenhuis Oost-Limburg Genk, Boehringer Ingelheim - (belgique@bitrialsupport.com)
hospital Italiano de Buenos Aires ABB, Buenos Aires F.D. Boehringer Ingelheim - (argentina@bitrialsupport.com)
the First Hospital of Jilin University Changchun, Boehringer Ingelheim - (china@bitrialsupport.com)

A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease (WILL-EMI)

Reference Study ID Number: WP45338 https://forpatients.roche.com/ - global-roche-genentech-trials@gene.com

NCT06998524
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Inclusion Criteria:
* Confirmed diagnosis of Type 3 von Willebrand disease (VWD), based on medical records * Preexisting medical record verifying the status of von Willebrand factor (VWF) inhibitor (positive or negative, including titer if available) * Adequate hematologic, hepatic, and renal function * For participants of childbearing potential: agreement to remain abstinent or adhere to the contraception requirements Additional Inclusion Criteria for Arms A and B: * Age ≥1 month at the time of signing Informed Consent/Assent Form * Documented previous use of on-demand therapy with intermittent (less than once a week) on-demand SOC therapy for VWD * Having ≥2 treated bleeds (except menstrual bleeds) with factor concentrate within 24 weeks prior to enrollment Additional Inclusion Criteria for Arm C: * Age ≥2 years at the time of signing Informed Consent/Assent Form * Documented and confirmed previous use of SOC prophylactic therapy for VWD (1-3 times weekly, as per prescribed dose) as described in the eligibility of Study WP45335 * Have completed all study requirements as defined in the WP45335 protocol for at least 24 weeks
Exclusion Criteria:
* Inherited or acquired bleeding disorder other than Congenital Type 3 VWD * History of gastrointestinal bleeding within 18 months prior to enrollment, or any previous diagnosis of angiodysplasia * History of intracranial hemorrhage * Previous or current treatment for thromboembolic disease or signs of thromboembolic disease * Other conditions (e.g., certain autoimmune diseases) that may increase risk of bleeding or thrombosis * History of clinically significant hypersensitivity associated with monoclonal antibody therapies or components of the emicizumab injection * Use of systemic immunomodulators (e.g., interferon) at enrollment or planned use during the study, with the exception of anti-retroviral therapy
DRUG: Emicizumab, DRUG: von Willebrand Factor (VWF) Concentrates, DRUG: Factor VIII (FVIII) Concentrates, DRUG: von Willebrand Factor (VWF) and Factor VIII (FVIII) Concentrates, DRUG: Bypassing Agents
Von Willebrand Disease, Type 3
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Study Locations

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Location Contacts
AOU Careggi Florence, Tuscany
Charlotte Maxeke Johannesburg Academic Hospital Johannesburg,
Erasmus MC Rotterdam,
Gerinnungszentrum Rhein-Ruhr;Gerinnungsambulanz Duisburg,
Great Ormond Street Hospital London,
Groupe Hospitalier Necker Enfants Malades Paris,
Hopital Claude Huriez - CHU Lille Lille,
Hospital Universitario La Paz Madrid,
Hospital Universitario Virgen del Rocio Seville,
Hämophiliezentrum Med. Klinik III/Institut für Transfusionsmedizin Frankfurt/M.,
IPS SURA Industriales Medellín Medellín,
IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan, Lombardy
Instytut Hematologii I Transfuzjologii Warsaw,
Kurume University Hospital Fukuoka, Kurume,
Manchester Royal Infirmary Manchester,
McGill University Health Center Montreal, Quebec
Nagoya University Hospital Aichi, Nagoya,
Sahlgrenska Universitetssjukhuset Gothenburg, Västra Götalands LÄN [se-14]
St Thomas' Hospital London,
The Hospital for Sick Children Toronto, Ontario
UC Davis Sacramento, California
UZ Leuven Gasthuisberg Leuven,
Universita' Degli Studi La Sapienza-Ist.Di Ematologia Rome, Lazio
Universitatsklinikum Bonn Bonn, North Rhine-Westphalia
University of Florida Gainesville, Florida
University of Kentucky Children's Hospital Lexington, Kentucky
University of Minnesota Medical Center Minneapolis, Minnesota
Virginia Commonwealth University Richmond, Virginia
Washington University School of Medicine St Louis, Missouri

Establishing Biomarkers and Clinical Endpoints in Myotonic Dystrophy Type 1 (END-DM1) Extension (END-EXT)

Jennifer Raymond - Jennifer.raymond@vcuhealth.org

NCT07700225
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Inclusion Criteria:
* Age 18 to 70 years (inclusive) * Written, voluntary informed consent must be obtained prior to any study procedures. In cases where a Legally Authorized Representative (LAR) provides consent, verbal assent will be obtained from the subject, as determined by the investigator and documented directly on the consent form. Capacity to consent will be determined by the neurologist at the Baseline visit and will be signed off on the Inclusion/Exclusion checklist. * Clinical diagnosis of DM1 based on research criteria or positive genetic test. The research criteria for clinical diagnosis of DM1 require myotonia, muscle weakness in a characteristic distribution, and history of similar findings in a first degree relative. Genetic testing confirmed the diagnosis of DM1 in \> 99% of individuals who satisfied these criteria. OR A diagnosis of CDM, which is defined as children having symptoms of myotonic dystrophy in the newborn period (\<30 days), such as hypotonia, feeding or respiratory difficulty, requiring hospitalization to a ward or to the neonatal intensive care unit for 3 days or more; and a genetic test suspicious of an expanded trinucleotide (CTG) repeat in the DMPK gene in the child or first degree relative. An expanded CTG repeat size in the child is considered greater than 200 repeats or E1-E4 classification (E1= 200-500, E2=500-1,000, E3=1,000-1,500, E4\>1,500)
Exclusion Criteria:
* Symptomatic renal or liver disease, uncontrolled diabetes or thyroid disorder, or active malignancy other than in situ skin cancer. * Current alcohol or substance use disorder. * Concurrent pregnancy or planned pregnancy during the course of the study. * Concurrent medical condition that would, in the opinion of the investigator or clinical evaluator. compromise performance on study measures. * Use of mexiletine or other anti-myotonia agents within 72 hours of any study visit.
DM1, Myotonic Dystrophy, Myotonic Dystrophy 1, Myotonic Dystrophy Type 1, Myotonic Dystrophy Type-1, Myotonic Dystrophy, Type 1 (DM1), Myotonic Muscular Dystrophy
DM1, END-EXT, END-DM1 Extension, Myotonic Dystrophy Type 1, Steinert's Disease, Muscular Dystrophy, Neuromuscular Disease, DMPK, Natural History, Myotonia, DMCRN, Myotonic Dystrophy Clinical Research Network
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Virginia Commonwealth University Richmond, Virginia Jennifer Raymond - (Jennifer.raymond@vcuhealth.org)

Endocardial Mapping With the CoreMap EP Mapping System (INvENI)

Jim Foster, SysEng - jfoster@coremapmedical.com

NCT06529978
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Inclusion Criteria:

• Subject has persistent or long-standing persistent AF, at the discretion of the investigator (Phase 1 \& 2)
• Subject has PerAF with no history of prior AF ablation therapy (Phase 3)
• Subject is 18 to 80 years of age
• Subject has presence of AF-related symptoms and is scheduled for clinically indicated standard of care AF ablation to manage PerAF (Phase 2 or 3) or long-standing PerAF (Phase 2)
• Subject is able to provide written informed consent
• Subject is able and willing to complete all study procedures
Exclusion Criteria:

• Any of the following within three months of enrollment:
• Myocardial infarction (MI)
• Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
• Confirmed thrombus on imaging
• Any of the following within six months of enrollment:
• Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
• Thromboembolic event (stroke)
• Any of the following cardiac conditions:
• New York Heart Association (NYHA) IV
• Left ventricular ejection fraction (LVEF) \< 30%
• Left atrial diameter \>55mm (anterioposterior) (Phase 3)
• Carotid stenting or endarterectomy
• Atrial or ventricular septal closure or left atrial appendage closure
• Implanted permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator; loop recorders are permitted.
• Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation
• Unstable angina
• Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve
• Moderate to severe mitral valve stenosis or other severe valvular disease
• Any blood clotting or bleeding abnormalities
• Contraindication to systemic anticoagulation
• AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible or non-cardiac cause
• Body mass index (BMI) \> 40 kg/m2
• Severe pulmonary disease, pulmonary hypertension, or any chronic respiratory condition
• Renal failure requiring dialysis or transplant
• Acute illness, active systemic infection, or sepsis
• Active drug or alcohol dependency
• Hypertrophic cardiomyopathy or cardiac amyloidosis
• Cor pulmonale
• Any contra-indication that may extend procedure time, at the discretion of the operator
• Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
• Subject considered part of vulnerable population
• Life expectancy less than one year
• Employee of the study site or Sponsor
• Subjects who are currently enrolled in another study that would directly interfere with this study
DEVICE: CoreMap EP Mapping System Mapping, DEVICE: CoreMap EP Mapping System Map-Guided Ablation
Persistent Atrial Fibrillation
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NCH Downtown Baker Hospital Naples, Florida
Na Homolce Hospital Praha Klanovice,
University of Vermont Medical Center Burlington, Vermont
Virginia Commonwealth University (VCU) Richmond, Virginia

Impact of Food Assistance on Treatment Adherence and Clinical Outcomes in Food-Insecure Cancer Pts

Massey CTO CPC Team - MasseyCPC@vcu.edu

NCT07706192
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Inclusion Criteria:
* Adult patients (≥18 years old) with a current diagnosis of cancer * Patients attending outpatient services at the VCU Massey Comprehensive Cancer Center * Patients who are willing to participate and provide informed consent * Responding "sometimes true" or "often true" to at least one of the two validate Hunger Vital Sign Screening questions
Exclusion Criteria:
* Patients who are unable to provide informed consent due to cognitive impairment or language barriers * Patients who are enrolled in other clinical trials that prohibit participation in additional research * Patients who do not consent to being included in the food insecurity registry * Patients with medical conditions other than cancer
OTHER: Food Assistance Program, OTHER: Standard of Care
Treatment Adherence
Treatment Adherence, Food Insecurity, Cancer Patients on Active Treatment
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Virginia Commonwealth University Richmond, Virginia Massey CTO CPC Team - (MasseyCPC@vcu.edu)

Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1

Dyne Clinical Trials - clinicaltrials@dyne-tx.com

NCT07486934
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Inclusion Criteria:
* Diagnosis of DM1 confirmed by molecular genetics with trinucleotide repeat size greater than (\>) 100. Historical results from clinical testing are acceptable. * Able to walk 10 meters and complete 5 times sit to stand independently (inserts or supports that don't go above the ankle are allowed). * Body mass index (BMI) less than (\<) 35 kilograms per meter square (kg/m\^2).
Exclusion Criteria:
* A known diagnosis of congenital DM1. * History of major surgical procedure (based on Investigator judgment) within 12 weeks prior to the start of screening, with the exception of implanted pacemaker or defibrillator. * Use of glucagon-like peptide 1 (GLP-1) agonist/incretin medications including semaglutide, dulaglutide, liraglutide, exenatide, or tirzepatide within a period of 5 half-lives of the medication prior to performing screening assessments. Note: Other inclusion and exclusion criteria may apply.
DRUG: zeleciment basivarsen (DYNE-101), DRUG: Placebo
Myotonic Dystrophy Type 1 (DM1), DM1, Myotonic Dystrophy, Steinert Disease, Steinert
DM1, Myotonic Dystrophy, Myotonic Dystrophy 1, Myotonia, Myotonic Dystrophy Type 1 (DM1), Dystrophy Myotonic, Myotonic Disorders, Steinert Disease, Steinert, Myotonic Muscular Dystrophy, HARMONIA, Dyne Therapeutics, Dyne, DYNE-101, zeleciment basivarsen, z-basivarsen
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AP-HP, Hôpital Raymond-Poincaré Garches, Pascal Laforet - (pascal.laforet@aphp.fr)
Aarhus University Hospital, Department of Neurology Aarhus,
Azienda Ospedaliero-Universitaria Sant'Andrea - UOC Neurologia Roma, Roma Matteo Garibaldi - (matteo.garibaldi@uniroma1.it)
CHU Marseille - Hôpital de la Timone (APHM) Marseille, Shahram Attarian, Professor - (shahram.attarian@ap-hm.fr)
CHU de Nantes - Hôtel-Dieu Nantes, Yann Pereon - (yann.pereon@univ-nantes.fr)
CHU de Toulouse - Hôpital Pierre-Paul Riquet Toulouse, Antoine Faurie-Grépon - (antoine.faurie-grepon@inserm.fr)
Centro Clinico Nemo Brescia, Fondazione Serena ETS Gussago, Brescia Massimiliano Filosto - (studiclinicinemobrescia@centrocliniconemo.it)
Centro Clinico Nemo Milano, Fondazione Serena ETS Milan, Milano Erica Di Natale - (erica.dinatale@centrocliniconemo.it)
Charité Universitätsmedizin Berlin Campus-Buch Muscle Research Unit Berlin, State of Berlin Elisabetta Gazzerro, Dr med - (Elisabetta.gazzerro@charite.de)
Fondazione Policlinico Universitario A. Gemelli IRCCS - Department of Women's, Child and Public Health Sciences - UOC Neuropsichiatria Infantile Roma, Roma Lorenzo Stivala - (lorenzo.stivala@policlinicogemelli.it)
Hospital Universitari Vall d'Hebron Barcelona, Raul Juntas Morales - (raul.juntas@vallhebron.cat)
Hospital Universitario Infanta Sofía San Sebastián de los Reyes, Madrid Gerardo Gutierrez Gutierrez - (g3.neuro@gmail.com)
Houston Methodist Neurological Institute Houston, Texas Estefania Porras - (eporras@houstonmethodist.org)
IU Health Neuroscience Center Indianapolis, Indiana Jennifer Terrell - (jkramey@iu.edu)
Kennedy Krieger Institute Baltimore, Maryland Demaya Starkes - (starkesd@kennedykrieger.org)
LMU Klinikum der Universität München Neurologische Klinik und Poliklinik Friedrich-Baur-Institut Campus Innenstadt Munich, Bavaria Riccardo Morbio - (Riccardo.Morbio@med.uni-muenchen.de)
National Center Hospital, National Center of Neurology and Psychiatry (NCNP) Kodaira, Tokyo Hirofumi Komaki - (komakihiro@ncnp.go.jp)
National Hospital Organization Osaka Toneyama Medical Center Toyonaka-Shi, Osaka Tsuyoshi Matsumura, MD, PhD - (matsumura.tsuyoshi.kq@mail.hosp.go.jp)
Niigata National Hospital, National Hospital Organization Kashiwazaki, Niigata Takashi Nakajima - (nakajima-md@mqb.biglobe.ne.jp)
Northern Care Alliance NHS Foundation Trust Salford, Lancashire Bethan Blackledge - (bethan.blackledge@nca.nhs.uk)
Pitié-Salpêtrière Hospital Paris, Nassima Ait Tahar - (n.ait-tahar@institut-myologie.org)
Radboud University Medical Center Nijmegen, Silvano Gefferie - (spierziektenresearchteam@radboudumc.nl)
Rare Disease Research, LLC Hillsborough, North Carolina Julia Zhu - (julia.zhu@rarediseaseresearch.com)
Rare Disease Research, LLC Hillsborough, North Carolina Hannah Nation - (hannah.nation@rarediseaseresearch.com)
Rigshospitalet, (Neuromuscular Clinic and Research Unit, Department 8077) Copenhagen, Nicolai Rasmus Preisler - (nicolai.rasmus.preisler@regionh.dk)
Roy Blunt NextGen Precision Health Institute Columbia, Missouri Heather McHatton - (heathermchatton@health.missouri.edu)
St Vincent's Hospital, Melbourne Fitzroy, Victoria Gayatri Jain - (gayatri.jain@svha.org.au) Alan Lai - (Alan.LAI@svha.org.au)
Stanford Neuroscience Health Center Palo Alto, California Anita Chacko - (neuromuscularresearch@stanford.edu)
The University of Osaka Hospital Suita-shi, Masanori Takahashi - (mtakahas@sahs.med.osaka-u.ac.jp)
The University of Texas Health Science Center at San Antonio San Antonio, Texas Tonya D Randolph - (Randolpht@uthscsa.edu)
UCLA Medical Center (Department of Neurology) Los Angeles, California Dennis Fernando - (defernando@mednet.ucla.edu)
UCSD - Altman Clinical and Translational Research Institute La Jolla, California Christian Farfan - (cfarfan@health.ucsd.edu)
UF Health: University of Florida Clinical Research Center Gainesville, Florida Debbye Landers - (debralanders@ufl.edu)
UZ Leuven Leuven, Britt Van Lancker - (britt.vanlancker@uzleuven.be)
UZA Edegem, Lauren Meers - (Lauren.Meers@uza.be)
University College London Hospitals NHS Foundation Trust National Hospital for Neurology and Neurosurgery London, England Vino Vivekanandam, PhD - (v.vivekanandam@ucl.ac.uk)
University of Maastricht Maastricht, Catharina Faber - (c.faber@mumc.nl)
University of Rochester Medical Center Rochester, New York Emily Verdaasdonk - (Emily_verdaasdonk@urmc.rochester.edu)
University of Utah Clinical Neurosciences Center Salt Lake City, Utah Michael Papadakis - (m.papadakis@utah.edu)
Universitätsklinikum Bonn AöR Zentrum für Neurologie Klinik für Neuroimmunologie und Neuromuskuläre Erkrankungen Bonn, North Rhine-Westphalia Jens Reimann, MD - (NME.Studien@ukbonn.de)
Universitätsmedizin Göttingen Göttingen, Lower Saxony Jana Zschuentzsch - (j.zschuentzsch@med.uni-goettingen.de)
Virginia Commonwealth University - Biotech One Richmond, Virginia Levi Headrick - (levi.headrick@vcuhealth.org)
Yamaguchi University Hospital Yamaguchi, Ube, Masayuki Nakamori, MD, PhD, Professor - (mnakamor@yamaguchi-u.ac.jp)

Metronomic Decitabine-Cedazuridine and Venetoclax in R/R AML, HR-MDS, HR/AP MPN

Massey IIT Research Operations - masseyepd@vcu.edu

NCT07710534
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Inclusion Criteria:
* Age ≥18 years at time of enrollment * Diagnosis of one of the following by World Health Organization (WHO) International Consensus Classification (ICC) criteria as determined by local assessment: * Relapsed/ refractory acute myeloid leukemia (R/R AML) as defined by ≥5% marrow blasts or unequivocal, measurable extramedullary disease * High Risk Myelodysplastic Syndrome (HR-MDS) (high/very high risk MDS by Revised International Prognostic Scoring System (IPSS-R) or Molecular International Prognostic Scoring System (IPSS-M) * high-risk accelerated-phase myeloproliferative neoplasm (HR/AP-MPN) defined by ≥10% blasts in blood or bone marrow * Eastern Cooperative Oncology Group (ECOG) Performance status 0-3 * White blood cell (WBC) count ≤25 × 109/Liter (L) (cytoreduction with hydroxyurea or steroids is allowed to achieve this) * Aspartate Aminotransferase (AST)/ Alanine Aminotransferase (ALT) ≤3 × upper limit of normal (ULN) (≤5 × ULN if due to leukemic involvement) * Total bilirubin ≤2 × ULN (unless the elevation is due to Gilbert's or hemolysis) * Creatinine clearance ≥ 30 milliliters / minute (mL/min) * Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of non-childbearing potential are those who have had a hysterectomy or bilateral oophorectomy, or who have completed menopause (no menses for at least one year and age ≥65 or follicle-stimulating hormone levels in the menopausal range). * Subjects and their partners with reproductive potential must agree to use effective contraceptive measures during the study and for 3 months after the last dose of study treatment. Effective contraception includes methods such as oral contraceptives or double-barrier method.
Exclusion Criteria:
* Prior use of hypomethylating agent and venetoclax in combination (Note, use of hypomethylating agent and/or venetoclax separately in alternative combinations with other drugs is allowed) * Inability to tolerate oral therapies, or medical co-morbidities that significantly impact parenteral absorption * Acute promyelocytic leukemia myeloproliferative neoplasm (MPN) with the Philadelphia chromosome translocation (BCR:ABL) translocation * Clinically significant cardiovascular disease as defined by unstable angina * New York Heart Association class III/IV congestive heart failure * Treatment with any investigational drug or therapy within 2 weeks of study treatment or 5 half-lives before the first dose of study treatment, whichever is shorter * Known hypersensitivity to azacitidine, venetoclax, decitabine or cedazuridine * Cytotoxic chemotherapy or prior azacitidine or decitabine within 2 weeks of first dose of study treatment * Concurrent use of AML/MDS/MPN therapies including lenalidomide, erythropoietin, luspatercept, cytotoxic chemotherapies, targeted agents, etc Note: hydroxyurea is allowed in Cycle 1 if necessary for cytoreduction and/or cytarabine not exceeding a maximum dose of 1 gram per meter squared (g/m2) in Cycle 1 is also allowed for cytoreduction * Uncontrolled intercurrent illness or infection (those with controlled HIV, hepatitis, or other chronic infections are eligible) * Untreated central nervous system disease * Pregnancy or breastfeeding * Other active malignancy requiring systemic therapy during duration of trial or otherwise would confound endpoints (eg, second malignancy present where survival is expected to be less than 6 months)
DRUG: Decitabine-cedazuridine plus venetoclax (DEC-C+VEN), DRUG: Azacitidine plus venetoclax (AZA+VEN)
Relapsed / Refractory AML, High Risk Myelodysplastic Syndrome, High Risk Myeloproliferative Neoplasms
Relapsed / Refractory AML, High Risk Myelodysplastic Syndrome, High Risk Myeloproliferative Neoplasms
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Virginia Commonwealth University Richmond, Virginia Acute Leukemia/Myeloid Malignancies CTO Team - (masseyhiit@vcu.edu)

A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040) (ADVANCE)

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or - LillyTrials@Lilly.com

NCT06672549
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Inclusion Criteria:
* Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening. * Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \[CDC-NCHS, 2022\]); OR * Applies to participant age between 12 and \<18 years old. Overweight as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart (CDC-NCHS, 2022), and at least 1 weight-related comorbidity, * hypertension * type 2 diabetes (T2D) * prediabetes * dyslipidemia * obstructive sleep apnea * metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD)
Exclusion Criteria:
* Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to: * gastric bypass * sleeve gastrectomy * restrictive bariatric surgery, such as Lap-Band® gastric banding, or * any other procedure intended to result in weight reduction. * Have a diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes. * Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records * Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state. * Have HbA1c \>9.0% (75 mmol/mol) as measured by central laboratory at screening. * Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2.
DRUG: Orforglipron, DRUG: Placebo
Obesity, Overweight
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Addenbrookes Hospital Cambridge,
Alder Hey Children's Hospital Liverpool,
All Childrens Hospital St. Petersburg, Florida
Ann and Robert Lurie Children's Hospital of Chicago Chicago, Illinois
Asan Medical Center Seoul,
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento Verona, Veneto
Azienda Ospedaliera Universitaria Policlinico de Modena Modena,
Azienda Ospedaliero Universitaria Maggiore della Carità Novara,
Azienda Ospedaliero Universitaria Meyer Florence,
Azienda Ospedaliero Universitaria di Parma Parma,
Barnsley Hospital NHS Foundation Trust Barnsley,
Boston Children's Hospital Boston, Massachusetts
Bristol Royal Hospital for Children Bristol,
CPQuali Pesquisa Clínica Sao Paulo São Paulo,
Carey Chronis MD Pediatric, Infant and Adolescent Medicine Oxnard, California
Centro Materno Infantil do Norte Porto,
Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC Culiacán,
Centro de Investigacion Farmacologica Del Bajio Sc León,
Chaim Sheba Medical Center Ramat Gan,
Chang Gung Medical Foundation-LinKou Branch Taoyuan,
Children's Healthcare of Atlanta - Center for Advanced Pediatrics Atlanta, Georgia
Children's Hospital Colorado Aurora, Colorado
Children's Hospital of Orange County - Orange Orange, California
Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center Saint Paul, Minnesota
Childrens Hospital of Los Angeles Los Angeles, California
Cleveland Clinic Cleveland, Ohio
Cliniques Universitaires Saint-Luc - PPDS Brussels,
Coastal Pediatric Associates Charleston, South Carolina
Corporacio Sanitaria Parc Tauli Sabadell,
Dell Children's Medical Center - PIN Austin, Texas
Driscoll Children's Hospital Corpus Christi, Texas
Duke Children's Primary Care Durham, North Carolina
Dynamed Clinical Research, LP d/b/a DM Clinical Research Houston, Texas
Dynamed Clinical Research, LP d/b/a DM Clinical Research Houston, Texas
ELIPSA - Elżbieta Lipska praktyka lekarska Ośrodek Endokrynologii i Diabetologii Dziecięcej Stanisławów Pierwszy,
ETG Justmed - PPDS Warsaw,
Florida Hospital- Center for Pediatric Research Orlando, Florida
FutureMeds - Targowek Warsaw,
Futuremeds sp. z o. o. Wroclaw,
Hadassah Medical Center Jerusalem,
Hanyang University Seoul Hospital Seoul,
Helen Devos Childrens' Hospital - PIN Grand Rapids, Michigan
Hospital Angeles Puebla Puebla City,
Hospital Cuf porto Porto,
Hospital Infantil Universitario Nino Jesus Madrid,
Hospital Regional Universitario de Malaga - Hospital Materno-Infantil Málaga,
Hospital Universitario Vall d'Hebron Barcelona,
Hospital Universitario de Araba (HUA)- Hospital Txagorritxu Vitoria-Gasteiz,
Hospital Universitario de Caxias do Sul Caxias do Sul,
Hospital da Luz Lisboa Lisbon,
Hull Royal Infirmary - MAIN Hull,
Innovacion y Desarrollo de Estrategias en Salud SA de CV Mexico City,
Instituto Hispalense de Pediatria Seville,
Instytut Diabetologii Warsaw,
Isesaki Municipal Hospital Isesaki-shi,
Johns Hopkins Children's Center Baltimore, Maryland
Kliniczny Szpital Wojewódzki Nr 2 im. SW Jadwigi Królowej w Rzeszowie Rzeszów,
Korea University Guro Hospital Seoul,
Krakowskie Centrum Medyczne Krakow,
L2IP - Instituto de Pesquisas Clínicas Brasília,
La Providence Pediatrics Clinic - Chemidox Clinical Trials Houston, Texas
Loma Linda University School of Medicine Loma Linda, California
Lucas Research, Inc Morehead City, North Carolina
Martin Diagnostic Clinic Tomball, Texas
Mayo Clinic - PIN Rochester, Minnesota
McGovern Medical School Houston, Texas
Medical University of South Carolina Children Hospital Charleston, South Carolina
MultiCare Health System - Mary Bridge Children's Health Center Tacoma, Washington
Nara Prefecture General Medical Center Nara, Nara,
National Cheng Kung University Hospital Tainan,
National Taiwan University Hospital Taipei,
Nationwide Children's Hospital Columbus, Ohio
Nemours Children's Health Orlando, Florida
Ninewells Hospital Dundee,
Northwick Park Hospital Harrow,
Norton Children's Endocrinology Louisville, Kentucky
Omaha Childrens Hospital Omaha, Nebraska
Osaka City General Hospital Osaka,
Ospedale Pediatrico Bambino Gesu Roma,
Ospedale Pediatrico Bambino Gesu Roma,
PanAmerican Clinical Research - Av. Antea 1032 - PPDS Juriquilla,
PanAmerican Clinical Research - Guadalajara Guadalajara,
Premium Clinic Wrocław Centrum Medyczne Wroclaw,
Rambam Health Care Campus Haifa,
Riley Hospital for Children Indianapolis, Indiana
Sagaekiminami Clinic Saga,
Saitama Medical University Hospital Iruma-Gun,
Schneider Children's Medical Center Petah Tikva,
Seattle Children's Research Institute - Hughes Building - PIN Seattle, Washington
Seoul National University Bundang Hospital Seongnam-si,
Shaare Zedek Medical Center Jerusalem,
Shiga General Hospital Moriyama,
Shikoku Medical Center for Children and Adults Zentsujichó,
Stamford Therapeutics Consortium Stamford, Connecticut
Sundance Clinical Research St Louis, Missouri
Texas Childrens Hospital Houston, Texas
Tokyo Medical Center Meguro-Ku,
UBMD Pediatrics Buffalo, New York
UCLA Mattel Children's Hospital Los Angeles, California
UMED Clinical Trials Lodz,
UNC Children's Hospital Chapel Hill, North Carolina
UPMC Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania
UZ Brussel Brussels, Brussels Capital
UZ Leuven Leuven,
University Hospital,Kyoto Prefectural University of Medicine Kyoto,
University of Arizona Tucson, Arizona
University of Illinois at Chicago Chicago, Illinois
University of Minnesota Masonic Children's Hospital Minneapolis, Minnesota
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma
VCU Health - Center for Endocrinology Diabetes and Metabolism Richmond, Virginia
Vanderbilt Health One Hundred Oaks Nashville, Tennessee
Velocity Clinical Research Omaha, Nebraska
Velocity Clinical Research Omaha, Nebraska
Velocity Clinical Research, Salt Lake City West Jordan, Utah
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials New Haven, Connecticut
Yitzhak Shamir Medical Center Ẕerifin, Central District

Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device

Richard C Webb, PhD - cwebb@rhaeos.com

NCT07050628
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Inclusion Criteria:

• Existing ventricular CSF shunt
• (Cohort A) A history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure
• (Cohort B) A shunt revision in the previous 7 days and the investigator judges that the patient will likely be discharged within 4 days of the enrollment date
• Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
• Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
• Subject is at least 5 years old but \< 22 years old
Exclusion Criteria:

• Shunt is not palpable or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
• Presence of an interfering open wound or edema in the study device measurement region
• Subject-reported history of serious adverse skin reactions to silicone-based adhesives
• Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
• Investigator judges that the subject is unlikely to successfully take reliable measurements at home
• Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
• Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
• Prior enrollment in this study
• Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
DEVICE: wireless thermal anisotropy measurement device
Hydrocephalus
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Rhaeos Inc. Chicago, Illinois Anna Somera - (clinical@rhaeos.com)
Virginia Commonwealth University Medical Center Richmond, Virginia Lisa Merck - (Lisa.Merck@vcuhealth.org)

Focusing on the Menopausal Transition to Improve Mid-Life Women's Health

Carrie Hsu, BA - carrie.hsu@cuanschutz.edu

NCT06975111
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Inclusion Criteria:
* aged 45-55 * In the late menopausal transition, defined as 60 days of amenorrhea but less than 365 days of amenorrhea18 * No current use of hormone therapy or hormonal contraception * Presence of a uterus and at least one ovary in order to track menstrual patterns * Have a smartphone and broadband access adequate to accept telehealth appointments
Exclusion Criteria:
* Lack of broadband access (activity and survey data will be collected electronically whenever possible and some visits will be via telehealth) * Lack of regular menstrual periods in mid-reproductive life (ages 25-38) when not on hormones or not pregnant. * Pregnancy or actively trying to get pregnant * Inability to adhere to study protocol schedule * Untreated alcoholism * Un- Diagnosed abnormal uterine bleeding * Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (MEN 2) for participants with a BMI\> 30 kg/m2.
DRUG: Metformin, DRUG: semaglutide, DRUG: Anti-hypertensives, DRUG: Lipid Lowering Medication, BEHAVIORAL: Life style intervention, DRUG: Fezolinetant, DRUG: Hormonal therapy
Menopause, Menopause Hot Flashes, Menopause Related Conditions, Cardiovascular
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University of Colorado-School of Medicine Aurora, Colorado
University of North Carolina, School of Medicine Chapel Hill, North Carolina Chelsea A Grinnan, RN - (REI_research@med.unc.edu) Makayla L Sweeney, BSc - (REI_research@med.unc.edu)
Virginia Commonwealth University Richmond, Virginia Keila Najera, MPH - (Keila.najera@vcuhealth.org) Michelle Orr, PhD, RN - (Keila.najera@vcuhealth.org)

Gene Therapy for HER-Positive Cancer (SENTRY-HER2) (SENTRY-HER2)

Allen Reha - allen.reha@vironexis.com

NCT07192432
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Inclusion Criteria:
* Age: ≥18 years of age * Histologically or cytologically confirmed diagnosis of HER-2 positive solid tumor as defined in the protocol * Part 1: presence of advanced or metastatic disease that has progressed during or following previous treatment * Part 2: Early stage HER-2 positive cancers with high risk for relapse following completion of SOC or after neoadjuvant systemic treatment * AAV specified capsid total antibody ≤1:400 * ECOG performance status of 0 or 1 * Life expectancy ≥3 months * Protocol-specified ranges for renal, liver, cardiac and pulmonary function * Protocol-specified ranges for hematology parameters
Exclusion Criteria:
* Hepatoxicity (AST or ALT \> 2x upper limit of normal) * Known active CNS or leptomeningeal disease * History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy * Pregnant or nursing (lactating) women * History of other malignancy within 5 years prior to screening as defined in protocol * History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity Concurrent anti-cancer treatment in another investigational trial
GENETIC: Dose Level 1, VNX-202, GENETIC: Dose Level 2, VNX-202, GENETIC: Dose Level 3, VNX-202, GENETIC: Dose Level 4, VNX-202
HER2 Expressing Solid Tumors
HER2+ breast cancer, HER2+ gastric cancer, Other HER+ cancer, HER2-low cancer
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Cleveland Clinic Cleveland, Ohio - (canceranswer@ccf.org)
Hackensack Medical Center Hackensack, New Jersey - (OncologyResearchReferral@hmhn.org)
Mayo Clinic Rochester, Minnesota
Mayo Clinic Rochester, Minnesota
Memorial Sloan Kettering Cancer Center New York, New York Jamie Walters - (waltersj@mskcc.org)
SCRI Denver DDU at HealthOne Denver, Colorado Julia Etchart - (julia.etchart@sarahcannon.com)
SCRI Oncology Partners Nashville, Tennessee SCRI Referrals - (SCRI.DDUreferrals@scri.com)
Thomas Jefferson University, Sidney Kimmel Cancer Center Philadelphia, Pennsylvania Steven Manobianco, MD - (steven.manobianco@jefferson.edu)
UT MD Anderson Cancer Center Houston, Texas Christine Tran - (cmtran@mdanderson.org)
VCU Massey CTO Phase I Solid Team Richmond, Virginia - (masseysiit@vcu.edu)
Valkyrie Clinical Trials Los Angeles, California Myo Zaw - (clinicaltrials@vctcare.com)

Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)

Trial Registration Coordinator - clinicaltrials@cslbehring.com

NCT07224360
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Inclusion Criteria:
* Adults aged greater than or equal to (\>=) 18 years on the day of signing the informed consent form. * Confirmed diagnosis of SCD of any genotype. * Experienced 1 to 12 VOCs requiring a visit to a medical facility and treatment with parenteral opioids or a parenteral nonsteroidal anti-inflammatory drug within the 12 months before Screening. * HU Regimen: * a. On stable and well-tolerated Hydroxyurea (HU) regimen for at least 30 days before Screening. * or * b. HU was discontinued or refused (eg, due to concern of side effects or lack of effect).
Exclusion Criteria:
* Absolute neutrophil count less than (\<) 2.5 ×10\^9 cells/Litre at Screening or Baseline (Week 1 Day 1). * If on SCD preventive medication, dose is not stable in the 30 days before Screening.
BIOLOGICAL: Anumigilimab, DRUG: Placebo
Sickle Cell Disease
Anemia, Genetic Disorder, Vaso-occlusive Crises
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AOUI Verona and University of Verona Verona,
Arthur M. Blank Hospital- Children's Healthcare of Atlanta Atlanta, Georgia
CHU Saint-Pierre Brussels,
CHU de Nantes, Hotel-Dieu Nantes,
Center For Cancer and Blood Disorders Bethesda, Maryland
Central Middlesex Hospital London,
Hammersmith Hospital Imperial College Healthcare NHS Trust London,
Institut Universitaire du Cancer de Toulouse Toulou,
Jacobi Medical Center The Bronx, New York
Ohio State University Columbus, Ohio
Southern Specialty Research Flowood, Mississippi
St George's University Hopsitals NHS Foundation Trust London,
The Foundation for Sickle Cell Disease Hollywood, Florida
UAMS Medical Center Little Rock, Arkansas
University of California Irvine Irvine, California
Virginia Commonwealth University Richmond, Virginia

LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis

Boehringer Ingelheim - clintriage.rdg@boehringer-ingelheim.com

NCT06632457
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Inclusion criteria:
• Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \>18 years
• Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)
• Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.
• Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF \<5% or FibroScan® with CAP \<288 dB/m is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis/steatohepatitis.
• Further inclusion criteria apply. Exclusion criteria:
• Current or history (\<5 years) of significant alcohol consumption, defined as an average of \>140 g/week in female patients and \>210 g/week in male patients, for a period of \>3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.
• Model of end-stage liver Disease (MELD) score \>12 due to liver disease
• History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to: * Portal hypertension-related upper gastrointestinal (GI) bleeding * Ascites * Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria
• Any of the following lab test result at screening * Albumin below \<3.5 g/dL (\<35.0 g/L) * International normalised ratio (INR) \>1.3 unless due to therapeutic anticoagulants * Total bilirubin (TBL) \>1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL \>1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is \<20% of TBL. * Alkaline phosphatase \>1.5x ULN * PLT \<100,000/µL (\<100 GI/L)
• History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis
• Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection
• Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))
• Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>5x ULN
• Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history
• History of liver transplantation or listed for liver transplantation
• History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment
• Further exclusion criteria apply
COMBINATION_PRODUCT: Survodutide, COMBINATION_PRODUCT: Placebo matching survodutide
Metabolic Dysfunction Associated Steatohepatitis
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310 Clinical Research Inglewood, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ASHA Clinical Research - Munster, LLC Hammond, Indiana Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Aberdeen Royal Infirmary Aberdeen, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Accellacare - South London Orpington, London, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Accellacare North London Northwood, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Access research Institute Brooksville, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Acclaim Clinical Research San Diego, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Acibadem City Clinic Tokuda University Hospital EAD Sofia, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Adobe Clinical Research, Llc Tucson, Arizona Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Advanced Research Institute New Port Richey, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Aintree University Hospital Liverpool, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Albert SchweitzerZiekenhuis Dordrecht, Boehringer Ingelheim - (nederland@bitrialsupport.com)
American Research Corporation - Austin Austin, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
American Research Corporation at the Texas Liver Institute San Antonio, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Arizona Liver Health - Tucson Tucson, Arizona Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ark Clinical Research Long Beach, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Aryav Superspeciality Hospital Ahemdabad, Boehringer Ingelheim - (india@bitrialsupport.com)
Asan Medical Center Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Asfendiyarov Kazakh National Medical University Almaty, Boehringer Ingelheim - (kazakhstan@bitrialsupport.com)
Atharva Multispecialty Hospital and research Centre Lucknow, Boehringer Ingelheim - (india@bitrialsupport.com)
Austin Health Heidelberg, Victoria Boehringer Ingelheim - (australia@bitrialsupport.com)
Az.Osp. Universitaria "Ospedali Riuniti" Foggia, Boehringer Ingelheim - (italia@bitrialsupport.com)
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo, Boehringer Ingelheim - (italia@bitrialsupport.com)
BAPS Pramukh Swami Hospital Surat, Boehringer Ingelheim - (india@bitrialsupport.com)
Basil Clinical Laurelton, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Beijing Ditan Hospital Capital Medical University Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Beijing Friendship Hospital Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Beijing Tsinghua Changgung Hospital Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Beijing Youan Hospital, Capital Medical University Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Ben Taub General Hospital Houston, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi Fatih, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
BioMed Research & Medical Center Miami, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Biopharma Informatic LLC McAllen, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Biopharma Informatic, Inc. Research Center Houston, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Bodyclinic sp. z o.o. sp.k. Warsaw, Boehringer Ingelheim - (polska@bitrialsupport.com)
Brooke Army Medical Center San Antonio, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Buenos Aires Macula S.A. Buenos Aires, Boehringer Ingelheim - (argentina@bitrialsupport.com)
CHU Amiens-Picardie Amiens, Boehringer Ingelheim - (france@bitrialsupport.com)
CIPREC Buenos Aires, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Cadena Care Institute, LLC Poway, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Carolina Researche Greenville, North Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Catalina Research Institute, Llc Montclair, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Cenara Clinical Research Cutler Bay, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Centex Studies, Inc. McAllen, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Centre Hospitalier Lyon Sud Pierre-Bénite, Boehringer Ingelheim - (france@bitrialsupport.com)
Centre Hospitalier Universitaire d'Angers Angers, Boehringer Ingelheim - (france@bitrialsupport.com)
Centre Hospitalier Universitaire de Bordeaux Pessac, Boehringer Ingelheim - (france@bitrialsupport.com)
Centre Hospitalier Universitaire de Liege Liège, Boehringer Ingelheim - (belgique@bitrialsupport.com)
Centre Hospitalier de Versailles Le Chesnay, Boehringer Ingelheim - (france@bitrialsupport.com)
Centro De Investigaciones Clínicas Viña Del Mar Viña del Mar, Boehringer Ingelheim - (chile@bitrialsupport.com)
Centro de Alta Especialidad del Estado de Veracruz Xalapa, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Centro de Investigacion Clinica del Pacifico (CICPA) Acapulco de Juárez, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Centro de Investigacion y Gastroenterologia Mexico City, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Centro de Investigacion y Gastroenterologia Mexico City, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Centro de Investigaciones Metabólicas (CINME) Buenos Aires, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Centro de Investigaciones Médicas UC Santiago, Boehringer Ingelheim - (chile@bitrialsupport.com)
Chang Gung Medical Foundation (CGMF) - Linkou Bran Taoyuan, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Changhua Christian Hospital Changhua, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Changi General Hospital Singapore, Boehringer Ingelheim - (singapore@bitrialsupport.com)
Changzhou Third People's Hospital Changzhou Shi, Boehringer Ingelheim - (china@bitrialsupport.com)
Charite - Universitatsmedizin Berlin Berlin, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Charter Research The Villages, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Charter Research The Villages, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Chelsea and Westminster Hospital London, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Chi Mei Medical Center Tainan, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Chiba University Hospital Chiba, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Chongqing Three Gorges Central Hospital Chongqing, Boehringer Ingelheim - (china@bitrialsupport.com)
Christchurch Hospital Christchurch, Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Chung Shan Medical University Hospital Taichung, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Chung-Ang University Hospital Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
ClinSearch, LLC Chattanooga, Tennessee Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinical Research Institute of Michigan, LLC Clinton Township, Michigan Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinical Research of South Nevada Las Vegas, Nevada Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinicos Asociados BOCM SC Mexico City, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Clinnova Research Solutions Orange, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Coastal Research Institute, LLC Fayetteville, North Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Complejo Hospitalario Universitario A Coruna A Coruña, Boehringer Ingelheim - (espana@bitrialsupport.com)
Complexo Hospitalario Universitario de Pontevedra Pontevedra, Boehringer Ingelheim - (espana@bitrialsupport.com)
Concord Repatriation General Hospital Concord, New South Wales
Connecticut Gastroenterology Clinical Research Foundation Bristol, Connecticut Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Conquest Research Winter Park, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Covenant Metabolic Specialist, LLC - Riverview Riverview, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Covenant Metabolic Specialists, LLC - Fort Myers Fort Myers, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Covenant Metabolic Specialists, LLC - University Park University Park, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
DHAT Reseach Institute Garland, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
DIM Clinica Privada Ramos Mejía, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Del Sol Research Management, LLC Tucson, Arizona Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet Budapest, Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
Delta Research Partners, LLC Bastrop, Louisiana Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Derby City General Hospital Derby, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Diagnostic Consultative Center Alexandrovska Sofia, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Diex Recherche Quebec Québec, Boehringer Ingelheim - (canada@bitrialsupport.com)
Digestive Research Alliance of Michiana South Bend, Indiana Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Dr. Rethy Pal Hospital Békéscsaba, Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
ECIR Miami Holdings LLC dba IMIC Miami, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
EMC Instytut Medyczny S.A. - Wroclaw Wroclaw, Boehringer Ingelheim - (polska@bitrialsupport.com)
Edificio Fleming La Serena, Boehringer Ingelheim - (chile@bitrialsupport.com)
Ege Universitesi Tip Fakultesi Izmir, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Ehime University Hospital Ehime, Toon, Boehringer Ingelheim - (nippon@bitrialsupport.com)
EmVenio Research Center at Prime Healthcare - Farmers Branch Garden City, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
EmVenio Research Center at Prime Healthcare - Riverdale Riverdale, Georgia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Endoscopic Research, Inc Orlando, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Entrust Clinical Research Miami, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Epic Clinical Research Lewisville, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Erasmus Medisch Centrum Rotterdam, Boehringer Ingelheim - (nederland@bitrialsupport.com)
Evolution Clinical Trials Hialeah Gardens, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Excel Clinical Research Las Vegas, Nevada Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
FDI Clinical Research San Juan, Boehringer Ingelheim - (support@bitrialsupport.com)
FOMAT Medical Research Oxnard, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ficramed Research Institute Poway, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
First Affiliated Hospital of Xi'an JiaoTong University Xi'an, Boehringer Ingelheim - (china@bitrialsupport.com)
First People's Hospital of Yunnan Province Kunming, Boehringer Ingelheim - (china@bitrialsupport.com)
Florida Medical Clinic, P.A. Zephyrhills, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Floridian Clinical Research Miami Lakes, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Fondazione Epatocentro Ticino Arzo, Boehringer Ingelheim - (suisse@bitrialsupport.com)
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico Milan, Boehringer Ingelheim - (italia@bitrialsupport.com)
Fondazione Policlinico Universitario Agostino Gemelli Irccs Rome, Boehringer Ingelheim - (italia@bitrialsupport.com)
Fondazione Policlinico Universitario Campus Bio-Medico Rome, Boehringer Ingelheim - (italia@bitrialsupport.com)
Franciscus Gasthuis Schiedam, Boehringer Ingelheim - (nederland@bitrialsupport.com)
Frimley Park Hospital Camberley, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Fujita Health University Hospital Toyoake, Aichi-ken Boehringer Ingelheim - (nippon@bitrialsupport.com)
Fukuiken Saiseikai Hospital Fukui-shi, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Future Innovative Treatments Colorado Springs, Colorado Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
FutureMeds Lodz Lodz, Boehringer Ingelheim - (polska@bitrialsupport.com)
FutureMeds Warszawa Centrum Warsaw, Boehringer Ingelheim - (polska@bitrialsupport.com)
FutureMeds Wroclaw Wroclaw, Boehringer Ingelheim - (polska@bitrialsupport.com)
GI Alliance Research - Dallas Dallas, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
GI Alliance Research - Mansfield Mansfield, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
GI Select Health Research, LLC Richmond, Virginia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Gastroenterology Associates of Central Georgia Macon, Georgia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Gazi Universitesi Tip Fakultesi Ankara, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
General Hospital of Ningxia Medical University Ningxia, Boehringer Ingelheim - (china@bitrialsupport.com)
Gifu Municipal Hospital Gifu, Gifu, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Glenny Corp - Centro Médico Saavedra Buenos Aires, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Global Clinical Professionals St. Petersburg, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Global Research Associates Homestead, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Great Lakes Gastroenterology Mentor, Ohio Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Guangzhou Eighth People's Hospital,Guangzhou Medical University Guangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Guangzhou First People's Hospital Guangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Gujarat Gastro and Vascular Hospital Surat, Boehringer Ingelheim - (india@bitrialsupport.com)
HASresearch San Antonio, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
HOP Dijon-Bourgogne Dijon, Boehringer Ingelheim - (france@bitrialsupport.com)
Hacettepe Universitesi Tip Fakultesi Ankara, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Hamamatsu University Hospital Shizuoka, Hamamatsu, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hi Tech and Global Research, LLC Coral Gables, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Hiroshima University Hospital Hiroshima, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hope Clinical Research Canoga Park, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Hopital Beaujon Clichy, Boehringer Ingelheim - (france@bitrialsupport.com)
Hopital Claude Huriez Lille, Boehringer Ingelheim - (france@bitrialsupport.com)
Hopital Cochin Paris, Boehringer Ingelheim - (france@bitrialsupport.com)
Hopital Henri Mondor Créteil, Boehringer Ingelheim - (france@bitrialsupport.com)
Hopital de la Croix-Rousse Lyon, Boehringer Ingelheim - (france@bitrialsupport.com)
Hopitaux Universitaires Pitié-Salpétrière Paris, Boehringer Ingelheim - (france@bitrialsupport.com)
Hopitaux Universitaires de Geneve (HUG) Geneva, Boehringer Ingelheim - (suisse@bitrialsupport.com)
Hospital Ampang Ampang, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Hospital Clinic de Barcelona Barcelona, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Clinico de Santiago Santiago de Compostela, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Das Clinicas Da Faculdade De Medicina Da USP Cerqueira César, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Hospital El Cruce San Juan Bautista, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Hospital General de Agudos Dr. J. M. Ramos Mejia Ciudad Autonoma Buenos Aires, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Hospital Puerta De Hierro Majadahonda, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitari Vall d'Hebron Barcelona, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario 12 de Octubre Madrid, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario Austral Pilar, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Hospital Universitario Joao de Barros Barreto Belém, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Hospital Universitario La Paz Madrid, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario Reina Sofia Córdoba, Andalusia Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universiti Sains Malaysia Kota Bharu, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Hospital das Clinicas da Universidade Federal de Minas Gerais (HC-UFMG) Belo Horizonte, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Hospital de Base São José do Rio Preto, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Hospitalar Moinhos de Vento Porto Alegre, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Huashan Hospital, Fudan University Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Hull Royal Infirmary Hull, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Hunan Provincial People's Hospital Changsha, Boehringer Ingelheim - (china@bitrialsupport.com)
Hyogo College of Medicine Hospital Hyogo, Nishinomiya, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hôpital Erasme Brussels, Boehringer Ingelheim - (belgique@bitrialsupport.com)
Hôpital Rangueil - CHU de Toulouse Toulouse, Boehringer Ingelheim - (france@bitrialsupport.com)
Hôpital de l'Archet Nice, Boehringer Ingelheim - (france@bitrialsupport.com)
ID Clinic Mysłowice, Boehringer Ingelheim - (polska@bitrialsupport.com)
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas Buenos Aires, Boehringer Ingelheim - (argentina@bitrialsupport.com)
IMA Clinical Research Austin Austin, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
IMA Clinical Research-Warren-69742 Warren Township, New Jersey Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Icahn School of Medicine at Mount Sinai New York, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Inha University Hospital Incheon, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Inland Empire Clinical Trials, LLC Rialto, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Innovation Medical Research Center Palmetto Bay, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Innovative Clinical Research Clarksville, Tennessee Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Insitute of Liver and Billiary Sciences New Delhi, Boehringer Ingelheim - (india@bitrialsupport.com)
Inspired GI Care Plumstead, Boehringer Ingelheim - (southafrica@bitrialsupport.com)
Institute of Gastroenterology, Hepatology and Metabolism LLP Almaty, Boehringer Ingelheim - (kazakhstan@bitrialsupport.com)
Institute of Science Tokyo Hospital Tokyo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Instituto de Diabetes, Obesidad y Nutrición S.C. Cuernavaca, Boehringer Ingelheim - (mexico@bitrialsupport.com)
International Center for Research Tampa, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
International University of Health and Welfare Narita Hospital Narita, Chiba Boehringer Ingelheim - (nippon@bitrialsupport.com)
Iowa Diabetes and Endocrinology Research Center West Des Moines, Iowa Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Israeli - Georgian Medical Research Clinic Healthycore LTD Tbilisi, Boehringer Ingelheim - (sakartvelo@bitrialsupport.com)
Istituto Clinico Humanitas Rozzano, Boehringer Ingelheim - (italia@bitrialsupport.com)
Iwate Medical University Hospital Shiwa-gun, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Japan Community Health Care Organization Hokkaido Hospital Hokkaido, Sapporo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Japanese Red Cross Musashino Hospital Musashino, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Jordan University Hospital Jordan, Boehringer Ingelheim - (support@bitrialsupport.com)
Jubilee Clinical Research, Inc Las Vegas, Nevada Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Juntendo University Hospital Tokyo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Juntendo University Shizuoka Hospital Shizuoka, Izunokuni, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kagawa University Hospital Kita-gun, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kagoshima University Hospital Kagoshima, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kanazawa University Hospital Ishikawa, Kanazawa, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kansas City Research Institute Kansas City, Missouri Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
King Abdulaziz Medical City, National Guard Health Affairs Riyadh, Boehringer Ingelheim - (saudi@bitrialsupport.com)
King Faisal Specialist Hospital and Research Center Riyadh, Boehringer Ingelheim - (saudi@bitrialsupport.com)
King's College Hospital London, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Klinical Investigations Group, LLC San Juan, Boehringer Ingelheim - (support@bitrialsupport.com)
Klinik Hietzing Vienna, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Klinikum Landshut AdöR der Stadt Landshut Landshut, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Klinikum Wels - Grieskirchen GmbH Wels, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Kobe University Hospital Kobe, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Koc Universitesi Hastanesi Istanbul, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Korea University Guro Hospital Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Krajska Nemocnice Liberec a.s. Liberec, Boehringer Ingelheim - (support@bitrialsupport.com)
Kumamoto Shinto General Hospital Kumamoto, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kumamoto University Hospital Kumamoto, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kurume University Hospital Fukuoka, Kurume, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Lake Center for Clinical Research Lady Lake, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Latin Clinical Trial Center San Juan, Boehringer Ingelheim - (support@bitrialsupport.com)
Liaocheng People's Hospital Liaocheng, Boehringer Ingelheim - (china@bitrialsupport.com)
Liverpool Hospital Liverpool, New South Wales Boehringer Ingelheim - (australia@bitrialsupport.com)
Louisiana Research Center, LLC Shreveport, Louisiana Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ltd "Health" Batumi, Boehringer Ingelheim - (sakartvelo@bitrialsupport.com)
M3 Wake Research, Inc. Raleigh, North Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
MHAT Sv. Ivan Rilski EOOD Gorna Oryahovitsa, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
MNGI Digestive Health, PA Minneapolis, Minnesota Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
McGill University Health Centre (MUHC) Montreal, Quebec Boehringer Ingelheim - (canada@bitrialsupport.com)
Medical Care and Research Mérida, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Medical Center New Rehabilitation Center EOOD Stara Zagora, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Medical Centre FutureMeds Krakow Krakow, Boehringer Ingelheim - (polska@bitrialsupport.com)
Medical Military Academy MHAT Sofia Sofia, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Medical University of Graz Graz, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Medical University of Vienna Vienna, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Memorial Bahçelievler Hospital Istanbul, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Metro Clinical Trials San Bernardino, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Midas Multispeciality Hospital Pvt. Ltd. Nagpur, Boehringer Ingelheim - (india@bitrialsupport.com)
Middlemore Hospital Papatoetoe, Auckland Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Mie University Hospital Tsu, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Monash Health Clayton, Victoria Boehringer Ingelheim - (australia@bitrialsupport.com)
MplusM - Best Choice Medical and Research Service Pembroke Pines, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
MplusM - Century Research Miami, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Multi-profile Hospital For Active Treatment-Uni Hospital Ltd. Panagyurishte, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Nagano Municipal Hospital Hanishina-gun, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Nagasaki Medical Center Nagasaki, Omura, Boehringer Ingelheim - (nippon@bitrialsupport.com)
NanFang Hosptial Guangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Nanjing Drum Tower Hospital Nanjing, Boehringer Ingelheim - (china@bitrialsupport.com)
Nanjing Jiangning Hospital Nanjing, Boehringer Ingelheim - (china@bitrialsupport.com)
Nara Medical University Hospital Nara, Kashihara, Boehringer Ingelheim - (nippon@bitrialsupport.com)
National Cheng Kung University Hospital Tainan, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
National Hospital Organization Kure Medical Center and Chugoku Cancer Center Kure, Boehringer Ingelheim - (nippon@bitrialsupport.com)
National Hospital Organization Kyushu Medical Center Fukuoka, Boehringer Ingelheim - (nippon@bitrialsupport.com)
National Hospital Organization Takasaki General Medical Center Takasaki-shi, Boehringer Ingelheim - (nippon@bitrialsupport.com)
National Taiwan University Hospital Taipei, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
National University Hospital Singapore, Boehringer Ingelheim - (singapore@bitrialsupport.com)
Neoclinical Research Hialeah, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Nepean Hospital Kingswood, New South Wales Boehringer Ingelheim - (australia@bitrialsupport.com)
New Zealand Clinical Research (NZCR) Grafton, Auckland Boehringer Ingelheim - (newzealand@bitrialsupport.com)
NewYork-Presbyterian Brooklyn Methodist Hospital Brooklyn, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Newcastle General Hospital Newcastle upon Tyne, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Nihon University Itabashi Hospital Tokyo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Niigata University Medical and Dental Hospital Niigata, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Ningbo Second Hospital Ningbo, Boehringer Ingelheim - (china@bitrialsupport.com)
Nippon Medical School Hospital Tokyo, Bunkyo-ku, Boehringer Ingelheim - (nippon@bitrialsupport.com)
North Texas Research Institute - Dallas Dallas, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Northshore Gastroenterology Research Westlake, Ohio Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
OMEGA Research Group Altamonte Springs, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Objective Health-Digestive Research of Central Texas Waco, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ObjectiveHealth-Columbia Digestive Health Research Columbia, South Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ObjectiveHealth-DSI Research - Springboro, LLC Springboro, Ohio Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ObjectiveHealth-Digestive Health Research of North Texas Wichita Falls, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
ObjectiveHealth-GI Associates Research Columbia, Missouri Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Obudai Egeszegugyi Centrum Budapest, Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
Ogaki Municipal Hospital Gifu, Ogaki, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Oita Cardiovascular Hospital Ōita, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Okayama University Hospital Okayama, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Om Research, LLC Victorville, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Optimus U Corporation-Miami-69452 Miami, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Options Health Research Tulsa, Oklahoma Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ordensklinikum Linz GmbH Linz, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Osaka City University Hospital Osaka, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Osaka Rosai Hospital Sakai, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Osmania Medical College & Hospital Hyderabad, Afzalgunj, Boehringer Ingelheim - (india@bitrialsupport.com)
Otto-von-Guericke-Universitat Magdeburg Magdeburg, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Palmetto Clinical Research Summerville, South Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak, Boehringer Ingelheim - (india@bitrialsupport.com)
Panthera Biopartners - Glasgow Glasgow, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Panthera Biopartners - Preston Preston, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Panthera Biopartners - Rochdale Rochdale, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Panthera Biopartners - Sheffield Sheffield, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Panthera Biopartners - York York, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Peking University People's Hospital Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Piedmont Hospital Atlanta, Georgia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
PingXiang People's Hospital Pingxiang, Boehringer Ingelheim - (china@bitrialsupport.com)
Pinnacle Clinical Research - Austin Austin, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pinnacle Clinical Research, LLC San Antonio, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pinnacle Clinical Research, LLC San Antonio, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Policlinico S. Orsola-Malpighi Bologna, Boehringer Ingelheim - (italia@bitrialsupport.com)
Post Graduate Institute of Medical Education and Research Chandigarh, Boehringer Ingelheim - (india@bitrialsupport.com)
Practice Dr Naeem Moosa Johannesburg, Boehringer Ingelheim - (southafrica@bitrialsupport.com)
Practice Dr Rosa Isela Luna Ceballos Veracruz, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Pusan National University Hospital Busan, Boehringer Ingelheim - (namhan@bitrialsupport.com)
QingDao Municipal Hospital Qingdao, Boehringer Ingelheim - (china@bitrialsupport.com)
Queen Elizabeth Hospital Putrajaya, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Queen Elizabeth Hospital Birmingham Edgbaston, Birmingham, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Recep Tayyip Erdogan Universitesi Egitim ve Arastirma Hastanesi Rize, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Regional Institute of Gastroenterology Hepatology "Prof. Dr. O. Fodor" Cluj-Napoca, Boehringer Ingelheim - (romania@bitrialsupport.com)
Renji Hospital Shanghai Jiaotong University School of Medicine Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Renmin Hospital of Wuhan University Wuhan, Boehringer Ingelheim - (china@bitrialsupport.com)
Research Associates of South Florida, LLC Miami, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Research Physicians Network Houston, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Research Site S.R.O. Pilsen, Boehringer Ingelheim - (support@bitrialsupport.com)
Rocco e Nazato Servicos Medicos LTDA São Paulo, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Royal Devon and Exeter Hospital, Wonford Exeter, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Royal Free Hospital London, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Royal Melbourne Hospital Parkville, Victoria Boehringer Ingelheim - (australia@bitrialsupport.com)
Royal Perth Hospital Perth, Western Australia Boehringer Ingelheim - (australia@bitrialsupport.com)
Ruijin Hospital Shanghai Jiao Tong University School of Medicine Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
SMG-SNU Boramae Medical Center Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
SR Kalla Memorial Hospital Jaipur, Boehringer Ingelheim - (india@bitrialsupport.com)
Saga University Hospital Saga, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Samsung Medical Center Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Santa SP. z o.o Lodz, Boehringer Ingelheim - (polska@bitrialsupport.com)
Sapporo Kosei General Hospital Sapporo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Schiff Center Liver Diseases Miami, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Scottsdale Medical Specialists, Ltd Scottsdale, Arizona Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Second Affiliated Hospital of medical college of Xi'an JiaoTong University Xi'an, Boehringer Ingelheim - (china@bitrialsupport.com)
Seichokai Bell Land General Hospital Sakai, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Semmelweis Egyetem Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika Budapest, Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
Sendai Tokushukai Hospital Sendai, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Seoul National University Hospital Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Shanghai East Hospital Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Shanghai General Hospital Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Shanghai Public Health Clinical Center Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Shimane University Hospital Izumo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Shin-Yurigaoka General Hospital Kanagawa, Kawasaki, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Shinshu University Hospital Nagano, Matsumoto, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Singapore General Hospital Singapore, Boehringer Ingelheim - (singapore@bitrialsupport.com)
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Sixth People's Hospital of Zhengzhou Zhengzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Soma Clinical Trials Denison, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Soon Chun Hyang University Hospital Bucheon Bucheon-si, Boehringer Ingelheim - (namhan@bitrialsupport.com)
South Denver Gastroenterology PC Englewood, Colorado Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
South Texas Research Institute - Brownsville Brownsville, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Southampton General Hospital Southampton, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Southern California Research Center Coronado, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Spital Judetean De Urgenta Satu Mare Satu Mare, Boehringer Ingelheim - (romania@bitrialsupport.com)
St George's Hospital Tooting, London, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
St. Josefs-Hospital Wiesbaden Wiesbaden, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Suita Hospital Suita-Shi, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Surat Institute of Digestive Sciences Surat, Boehringer Ingelheim - (india@bitrialsupport.com)
Synergy Healthcare Bradenton, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Synergy Healthcare of Tampa Brandon, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Taichung Veterans General Hospital Taichung, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Taipei Medical University Hospital Taipei, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Taipei Veterans General Hospital Taipei, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Tandem Clinical Research Marrero, Louisiana Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Technische Universitat Dresden Dresden, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Texas Clinical Research Institute, LLC Arlington, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
The Affiliated Hospital of Hangzhou Normal University Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
The Fifth People's Hospital of Suzhou Suzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of Henan University of Science and Technology Luoyang, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of NanChang University Nanchang, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of Wenzhou Medical University Wenzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital, Zhejiang University Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated hospital of Fujian Medical University Fuzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Hospital of Jiaxing Jiaxing, Boehringer Ingelheim - (china@bitrialsupport.com)
The First People's Hospital of Foshan Foshan, Boehringer Ingelheim - (china@bitrialsupport.com)
The Institute for Liver Health II DBA Arizona Clinical Trials Peoria, Arizona Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
The Ohio State University Wexner Medical Center Columbus, Ohio Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
The Second Affiliated Hospital to Nanchang University Nanchang, Boehringer Ingelheim - (china@bitrialsupport.com)
The Second Hospital of Nanjing Nanjing, Boehringer Ingelheim - (china@bitrialsupport.com)
The Sixth People's Hospital of Shenyang Shenyang, Boehringer Ingelheim - (china@bitrialsupport.com)
The Speciality Hospital (TSH) Amman, Boehringer Ingelheim - (support@bitrialsupport.com)
The Third People's Hospital of Shenzhen Shenzhen, Boehringer Ingelheim - (china@bitrialsupport.com)
The Third People's Hospital of Zhenjiang Zhenjiang, Boehringer Ingelheim - (china@bitrialsupport.com)
The University of Osaka Hospital Suita-shi, Boehringer Ingelheim - (nippon@bitrialsupport.com)
The University of Tokyo Hospital Bunkyō City, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Tianjin Second People's Hospital Tianjin, Boehringer Ingelheim - (china@bitrialsupport.com)
Tianjin Third Central Hospital Tianjin, Boehringer Ingelheim - (china@bitrialsupport.com)
Tokai University Hospital Isehara-shi, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Tokyo Medical University Hospital Tokyo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Tokyo Medical University Ibaraki Medical Center Ibaraki, Inashiki-gun, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Toranomon Hospital Tokyo, Minato-ku, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Toronto Liver Centre Toronto, Ontario Boehringer Ingelheim - (canada@bitrialsupport.com)
US Digestive Health Wyomissing, Pennsylvania Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
US Digestive Health Wyomissing, Pennsylvania Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
US Digestive Health Wyomissing, Pennsylvania Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Uludag Universitesi Tip Fakultesi Bursa, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan, Boehringer Ingelheim - (china@bitrialsupport.com)
Universidade Estadual Paulista "Julio De Mesquita Filho" Botucatu, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Universidade Federal do Rio Grande do Sul Porto Alegre, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Universidade Federal do Rio de Janeiro Barra, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Universita Degli Studi di Torino Torino, Boehringer Ingelheim - (italia@bitrialsupport.com)
Universitair Ziekenhuis Antwerpen Edegem, Boehringer Ingelheim - (belgique@bitrialsupport.com)
Universitatsklinikum Heidelberg Mannheim, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitatsklinikum Heidelberg Mannheim, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitatsklinikum Schleswig-Holstein, Campus Lubeck Lübeck, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
University Hospital Kyoto Prefectural University of Medicine Kyoto, Boehringer Ingelheim - (nippon@bitrialsupport.com)
University Hospital Zurich Zurich, Boehringer Ingelheim - (suisse@bitrialsupport.com)
University Malaya Medical Centre Kuala Lumpur, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD Sofia, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
University of British Columbia Vancouver, British Columbia Boehringer Ingelheim - (canada@bitrialsupport.com)
University of Calgary Calgary, Alberta Boehringer Ingelheim - (canada@bitrialsupport.com)
University of Miyazaki Hospital Miyazaki, Boehringer Ingelheim - (nippon@bitrialsupport.com)
University of Nebraska Medical Center Omaha, Nebraska Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Rochester Medical Center Rochester, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Università di Modena e Reggio Emilia Modena, Boehringer Ingelheim - (italia@bitrialsupport.com)
Universität Des Saarlandes Homburg, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Frankfurt Frankfurt, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH Bochum, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Köln (AöR) Cologne, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Münster Münster, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Würzburg AÖR Würzburg, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie Lublin, Boehringer Ingelheim - (polska@bitrialsupport.com)
VCU Medical Center West Hospital Richmond, Virginia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Vanderbilt University Medical Center Nashville, Tennessee Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research, Austin Austin, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research, Bristol Bristol, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Velocity Clinical Research, San Diego La Mesa, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research, Seattle Seattle, Washington Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research, Waco Waco, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research-Chula Vista Chula Vista, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research-Huntington Park Huntington Park, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research-Spokane-69716 Spokane, Washington Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Viable Clinical Research Bridgewater, Nova Scotia Boehringer Ingelheim - (canada@bitrialsupport.com)
Vseobecna Fakultni Nemocnice v Praze Prague, Boehringer Ingelheim - (support@bitrialsupport.com)
Waikato Hospital Hamilton, Waikato Region Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Wakayama Medical University Hospital Wakayama, Boehringer Ingelheim - (nippon@bitrialsupport.com)
West China Hospital, Sichuan University Chengdu, Boehringer Ingelheim - (china@bitrialsupport.com)
West Michigan Clinical Research Center Wyoming, Michigan Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Westmead Hospital Westmead, New South Wales Boehringer Ingelheim - (australia@bitrialsupport.com)
Yashoda Hospitals - Secunderabad Secunderabad, Boehringer Ingelheim - (india@bitrialsupport.com)
Yokohama City University Hospital Yokohama, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Yonsei University Wonju Severance Christian Hospital Wŏnju, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Zenos Clinical Research Dallas, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Zhejiang Hospital Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Ziekenhuis Oost-Limburg Genk, Boehringer Ingelheim - (belgique@bitrialsupport.com)
the First Hospital of Jilin University Changchun, Boehringer Ingelheim - (china@bitrialsupport.com)

A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Clinical Trials Administrator - clinicaltrials@regeneron.com

NCT06769698
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Key
Inclusion Criteria:

• Have histologically confirmed (by local pathology) R/M HNSCC that is considered incurable by local therapies
• Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx (patients with cervical neck node SCC with occult primary as described in the protocol
• PD-L1 expression Combined Positive Score (CPS) ≥1 documented with a previously PD-L1 obtained Immunohistochemistry (IHC) result prior to screening, as described in protocol
• Oropharynx cancer participants only: HPV status, based on a previously documented result prior to screening, must have been established in a surgical biopsy specimen or a core biopsy specimen as described in the protocol
• At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as described in the protocol
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ and bone marrow function as described in the protocol Key
Exclusion Criteria:
Medical Conditions
• Participants who have Progressive Disease (PD) within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC as described in the protocol
• Participants who have a primary tumor site of nasopharynx, paranasal sinus or salivary gland (any histology)
• Head and neck SCC with unknown primary site as described in the protocol
• Participants with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date as described in the protocol
• History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management
• History or current evidence of significant cardiovascular disease including, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classification III and IV), unstable angina, serious uncontrolled arrhythmia, and myocardial infarction 6 months prior to study enrollment. Prior/Concomitant Therapy
• Participants who have received prior systemic anticancer therapy in the R/M HNSCC setting as described in the protocol
• Participants with a condition requiring corticosteroid therapy (\>10 mg prednisone/prednisolone/day or equivalent) within 14 days of the first dose of study drug as described in the protocol Note: Other protocol defined Inclusion/ Exclusion Criteria apply
DRUG: FDC fianlimab+cemiplimab, DRUG: Cemiplimab, DRUG: Placebo
Head and Neck Squamous Cell Carcinoma (HNSCC)
Recurrent or Metastatic (R/M), Positive for Programmed Death Ligand 1 (PD-L1) Expression, Human Papillomavirus (HPV)
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Asplundh Cancer Pavilion Willow Grove, Pennsylvania
Cairns Hospital Cairns,
Centre Jean Perrin Clermont-Ferrand, Auvergne-Rhône
Centro Oncologico de Galicia A Coruña,
Complejo Hospitalario Universitario de a Coruna A Coruña, Galicia
Emory University School Of Medicine Atlanta, Georgia
Henry Ford Cancer Institute/Henry Ford Health System Detroit, Michigan
Hopital Europeen Geroges Pompidou AP-HP Paris, Île-de-France Region
Hospital Clinic Barcelona, Catalonia
Hospital Universitario La Paz Madrid,
Hospital Universitario Miguel Servet Zaragoza,
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario de Navarra Pamplona,
Humanitas Cancer Center Pieve Emanuele, Milan
IRCCS Ospedale San Raffaele Milan, Lombardy
Inova Schar Cancer Institute Fairfax, Virginia
Istituto Europeo Di Oncologia Milan,
Joe Arrington Cancer Research & Treatment Center Lubbock, Texas
Northwestern University Chicago, Illinois
Norton Cancer Institute Louisville, Kentucky
Ohio State University Columbus, Ohio
Oncology Hematology West P.C. dba Nebraska Cancer Specialists Omaha, Nebraska
Orlando Health Orlando, Florida
Peter MacCallum Cancer Centre (PMCC) Melbourne, Victoria
Renovatio Clinical The Woodlands, Texas
Samuel Oschin Cancer Center Los Angeles, California
St. Elizabeth Healthcare Edgewood, Kentucky
Timone Hospital - AP-HM Marseille, Bordeaux
University Hospital Vall d'Hebron Barcelona,
University of California Los Angeles Los Angeles, California
University of Rochester Rochester, New York
University of Tennessee Medical Center Knoxville, Tennessee
Vanderbilt-Ingram Cancer Center Nashville, Tennessee
Virginia Commonwealth University Massey Cancer Center Richmond, Virginia
Wide Bay Hospital and Health Service Hervey Bay, Queensland
Wide Bay Hospital and Health Service - Cancer Care Services - Bundaberg Bundaberg, Queensland

Study of ABBV-142 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Idiopathic Pulmonary Fibrosis

ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com

NCT07230288
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Inclusion Criteria:
\- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) within 7 years prior to screening, confirmed by the investigator at screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained within 12 months of the screening visit and verification of usual interstitial pneumonia(UIP) or probable UIP.
Exclusion Criteria:
* History of stroke within 6 months prior to screening * In the opinion of the investigator, other clinically significant pulmonary abnormalities * History of any malignancy up to 5 years prior screening visit, except for successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix.
DRUG: ABBV-142, DRUG: Placebo for ABBV-142
Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
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Study Locations

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Acibadem City Clinic Tokuda University Hospital EAD /ID# 277846 Sofia,
Caritas-Krankenhaus St. Maria gGmbH /ID# 278138 Donaustauf, Bavaria
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou /ID# 278333 Rennes, Ille-et-Vilaine
Centre d'Investigation Clinique Mauricie /ID# 277949 Trois-Rivières, Quebec
China Medical University Hospital /ID# 278039 Taichung,
Christie Clinic on University /ID# 277871 Champaign, Illinois
Clinical Research Specialists - Kissimmee /ID# 279184 Kissimmee, Florida
Diagnostic Consultative Center Convex /ID# 277848 Sofia,
Diagnostic Consultative Center Convex /ID# 277849 Sofia,
Dr Hannes J van Rensburg inc /ID# 278278 Cape Town, Western Cape
Dr JM Engelbrecht Trial Site /ID# 278287 Somerset West, Western Cape
Eastern Health /ID# 278245 Box Hill, Victoria
Edinburgh Royal Infirmary - NHS Lothian /ID# 278631 Edinburgh, Edinburgh, City of
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 277724 Athens, Attica
General Hospital of Thessaloniki George Papanikolaou /ID# 277819 Thessaloniki,
Gulhane Egitim ve Arastirma Hastanesi /ID# 278944 Ankara, Antalya
Hannibal Regional Hospital /ID# 277984 Hannibal, Missouri
Henry Ford Hospital /ID# 277843 Detroit, Michigan
Hopital Arnaud de Villeneuve /ID# 278322 Montpellier, Herault
Hopital Avicenne /ID# 279212 Bobigny, Île-de-France Region
Hospital Clinico Universitario de Valencia /ID# 277921 Valencia,
Hospital Universitari i Politecnic La Fe /ID# 278478 Valencia,
Inje University Haeundae Paik Hospital /ID# 278000 Busan, Busan Gwang Yeogsi
Inova Fairfax Hospital /ID# 278469 Falls Church, Virginia
Institute For Pulmonary Diseases Of Vojvodina /ID# 278499 Kamenitz, Sremski Okrug
Jefferson Health Honickman Center /ID# 279127 Philadelphia, Pennsylvania
Kaohsiung Chang Gung Memorial Hospital /ID# 278043 Kaohsiung City,
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 278029 Kaohsiung City,
Klinikum Konstanz /ID# 278139 Konstanz, Baden-Wurttemberg
Linkou Chang Gung Memorial Hospital /ID# 278042 Taoyuan City,
Lung Research Queensland /ID# 278838 Nundah, Queensland
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 278943 Istanbul,
NHO Kinki Chuo Chest Medical Center /ID# 280225 Sakai-shi, Osaka
National Taiwan University Hospital /ID# 278041 Taipei,
Norfolk and Norwich University Hospital /ID# 278224 Norwich, Norfolk
Royal Brompton Hospital /ID# 278007 London, Greater London
Royal Papworth Hospital NHS Foundation Trust /ID# 278055 Cambridge, Cambridgeshire
Sec Clinical Research - East - Dothan - Graceland /ID# 278328 Dothan, Alabama
Seoul National University Bundang Hospital /ID# 278059 Seongnam-si, Gyeonggido
Taipei Veterans General Hospital /ID# 278038 Taipei,
The Catholic University Of Korea, Bucheon St. Mary'S Hospital /ID# 278068 Bucheon-si, Gyeonggido
The University of Alabama at Birmingham /ID# 277613 Birmingham, Alabama
UCLH NHS FT - University College Hospital /ID# 279198 London, Greater London
Unidade Local de Saude de Loures-Odivelas-Hospital Beatriz Angelo /ID# 278357 Loures, Lisbon District
Unidade Local de Saude de Matosinhos EPE /ID# 277980 Senhora da Hora, Porto District
Unidade Local de Saude do Algarve, EPE /ID# 278388 Faro,
University Clinical Center Serbia /ID# 278496 Belgrade, Beograd
University General Hospital of Heraklion /ID# 277717 Heraklion, Crete
University General Hospital of Patras /ID# 277726 Pátrai, Achaia
University Hospital Southampton /ID# 278223 Southampton, Hampshire
University Hospital of Ioannina /ID# 277719 Ioannina,
University Multiprofile Hospital For Active Treatment Sveti Georgi - Plovdiv /ID# 279367 Plovdiv,
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski /ID# 277845 Pleven,
University of Michigan Health System - Ann Arbor /ID# 279994 Ann Arbor, Michigan
Virginia Commonwealth University Medical Center /ID# 277992 Richmond, Virginia
Vitamed Galaj i Cichomski Sp.j. /ID# 278145 Bydgoszcz, Kuyavian-Pomeranian Voivodeship
Yonsei University Health System Severance Hospital /ID# 278166 Seoul, Seoul Teugbyeolsi

Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma

The Ohio State University Comprehensive Cancer Center - OSUCCCClinicaltrials@osumc.edu

NCT06536049
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Inclusion Criteria:
* One of the following CD20+ B-cell non-Hodgkin lymphoma subtypes (note, documentation of CD20 positivity by flow cytometry and/or immunohistochemistry is based on any representative pathology report) * Diffuse large B-cell lymphoma (DLBCL), including DLBCL, not otherwise specified (NOS); T-cell/histiocyte-rich large B-cell lymphoma; and Epstein-Barr virus-positive DLBCL, NOS * High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangements (double-hit or triple-hit lymphoma) or HGBL, NOS * Primary mediastinal B-cell lymphoma (PMBCL) * Follicular lymphoma, grade 3b (also known as follicular large B-cell lymphoma in the 5th edition of World Health Organization \[WHO\] classification of lymphoid neoplasms) * Patients with previously diagnosed indolent lymphoma (follicular lymphoma or marginal zone lymphoma but not lymphoplasmacytic lymphoma or small lymphocytic lymphoma/chronic lymphocytic leukemia) who have transformed to any of the above lymphoma subtypes are eligible * Patients must have relapsed or refractory aggressive B-cell lymphoma and received prior treatment with an anthracycline in combination with an anti-CD20 monoclonal antibody: * ≥ 2 prior systemic lymphoma treatments OR * ≥ 1 prior systemic lymphoma treatment in patients with high-risk disease defined as primary refractory or relapsed within 12 months of completing anthracycline-based frontline treatment who are ineligible for chimeric antigen receptor (CAR) T cells per the treating physician. The reason for CAR T-cell treatment ineligibility should be documented * Prior treatment with a BTK inhibitor is allowed if stopped due to lymphoma progression or treatment completion but not intolerance * Prior treatment with autologous stem cell transplant (ASCT) is allowed if ≥ 100 days prior to enrollment * Prior treatment with CAR T cells is allowed if ≥ 30 days prior to enrollment * Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of ibrutinib or epcoritamab in patients \< 18 years of age, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Measurable disease (defined as \> 1.5 cm in diameter) or at least one PET fludeoxyglucose F-18 (FDG) avid area of disease * Absolute neutrophil count (ANC) ≥ 1,000/mcL * Platelet count ≥ 75,000/mcL. Platelet count ≥ 50,000/mcL is allowed in case of bone marrow involvement and/or splenomegaly * Hemoglobin ≥ 8 g/dL * Transfusion and/or growth factor support within 7 days (or 14 days in case of long-acting growth factors such as pegylated granulocyte colony-stimulating factor \[G-CSF\]) of enrollment to meet these requirements is not permitted * Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN) (unless due to Gilbert's disease or hemolysis in which case bilirubin must be \< 3 x ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) \< 3 x institutional ULN * Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) \< 3 x institutional ULN * Creatinine clearance \> 45 mL/min calculated by Cockcroft-Gault. Patients on dialysis are not eligible * The effects of ibrutinib and epcoritamab on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 2 weeks before initiation of treatment, for the duration of study participation and for 12 months after completing treatment. Should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately. Men must agree to refrain from sperm donation for at least 12 months after the last dose of epcoritamab * Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[β-hCG\]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study * Patients must have the ability to understand and the willingness to sign a written informed consent document and Health Insurance Portability and Accountability Act (HIPAA) consent document. Voluntary written consent must be given before the performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
Exclusion Criteria:
* Prior therapy with a bispecific antibody targeting CD3 and CD20 * Prior lymphoma therapy should be completed greater than two weeks before the start of protocol therapy, except for corticosteroids used for palliation of symptoms * Patients who require immediate cytoreductive therapy for their lymphoma per the treating physician's assessment are ineligible * Patients with a history of allogeneic stem cell transplantation are excluded unless the transplant was \> 180 days before the first scheduled dose of ibrutinib AND the patient does not have evidence of active acute or chronic graft versus host disease AND the patient must not have taken immunosuppressive medications associated with the transplant for at least 1 month before the first scheduled dose of ibrutinib * Ongoing systemic treatment with a strong CYP3A inhibitor or inducer. Treatment with any strong CYP3A inhibitor or inducer needs to be stopped for 5 half-lives prior to starting treatment on trial * Major surgery within 4 weeks before the start of treatment other than surgery performed for lymphoma diagnosis * Known active central nervous system (CNS) involvement by lymphoma. Patients who are enrolled and subsequently identified to have pathologic confirmation of CNS involvement by lymphoma may be continued on the study at the discretion of the principal investigator * Active uncontrolled infection or infection requiring intravenous (IV) antibiotic therapy for \> 2 consecutive days within 2 weeks prior to the first dose of study drug * Evidence of current uncontrolled or symptomatic cardiovascular conditions, including, uncontrolled cardiac arrhythmias, history of or symptomatic congestive heart failure (New York Heart Association \[NYHA\] class III or greater), unstable angina, or myocardial infarction within the past 6 months. Poorly controlled or clinically significant atherosclerotic vascular disease including angioplasty, cardiac or vascular stenting within 6 months of enrollment * Known liver cirrhosis with moderate to severe hepatic impairment (Child-Pugh class B or C) * Clinically significant pulmonary disease or history of bronchospasm requiring intubation, or clinically significant active interstitial lung disease or pneumonitis * History of cerebrovascular accident or transient ischemic attack within the 6 months before day 1, cycle 1 of treatment * Any prior history of intracranial hemorrhage * Clinically significant known bleeding diatheses or platelet dysfunction disorders. * Receiving treatment with coumadin/warfarin * Known gastrointestinal disease or gastrointestinal procedure that will significantly interfere with the oral absorption or tolerance of ibrutinib including the inability to swallow pills/capsules * Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol * Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent * Prior solid organ transplant * History of other malignancies that could affect compliance with the protocol or interpretation of results in the opinion of the investigator * Participation in other interventional clinical trials, including those with other investigational agents not included in this trial, within 21 days of the first scheduled dose of ibrutinib (cycle 1 day -7) * Known history of HIV, active hepatitis C infection (HCV ribonucleic acid \[RNA\] polymerase chain reaction \[PCR\]-positive) and/or active hepatitis B infections (HBV DNA PCR-positive). If hepatitis B core (HBc) antibody is positive, the patient must be evaluated for the presence of HBV DNA by PCR. If HCV antibody is positive, the patient must be evaluated for the presence of HCV RNA by PCR. Patients with positive HBc antibody and negative HBV DNA by PCR are eligible. Patients with positive HCV antibody and negative HCV RNA by PCR are eligible * Pregnant or breastfeeding women are excluded from this study. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with ibrutinib or epcoritamab, breastfeeding should be discontinued if the mother is treated with ibrutinib or epcoritamab * Patients with ongoing clinically significant grade ≥ 2 toxicity from prior therapy
PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, BIOLOGICAL: Epcoritamab, DRUG: Ibrutinib, PROCEDURE: Positron Emission Tomography
Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Grade 3b Follicular Lymphoma, Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements, Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified, Recurrent Primary Mediastinal Large B-Cell Lymphoma, Recurrent Transformed Non-Hodgkin Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory Grade 3b Follicular Lymphoma, Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements, Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified, Refractory Primary Mediastinal Large B-Cell Lymphoma, Refractory Transformed Non-Hodgkin Lymphoma
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Ohio State University Comprehensive Cancer Center Columbus, Ohio Yazeed Sawalha - (Yazeed.sawalha@osumc.edu)
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota Alisha Seay - (seayx020@umn.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Massey CTO Lymphoma/Myeloma Team - (masseyhemmlg@vcu.edu)