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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)

Contact(s):

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

Principal Investigator:

System ID: 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.

Interventions: DRUG: Cemiplimab, DRUG: cemiplimab plus fianlimab, DRUG: cemiplimab + REGN7075, OTHER: ctDNA testing

Conditions: Colo-rectal Cancer

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Study Locations

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Location	Contacts
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
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
Virginia Commonwealth University - Massey Richmond, Virginia

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

Contact(s):

Nabil Jubran, MS - njubran@adagiomedical.com

Principal Investigator:

System ID: 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)

Interventions: DEVICE: Ultra Low Temperature Ablation (ULTA)

Conditions: Ventricular Tachycardia, Sustained, Ventricular Tachycardia, Monomorphic

Keywords: 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)

Contact(s):

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

Principal Investigator:

System ID: NCT07165028

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Interventions: DRUG: Tirzepatide, DRUG: Retatrutide, DRUG: Placebo

Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease

Keywords: 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 University 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, West-Vlaanderen
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 Bhubaneswar,
All India Institute of Medical Sciences Bhubaneswar,
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, Antwerpen
Aotearoa Clinical Trials Auckland,
Aotearoa Clinical Trials - Whangarei Whangarei,
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Troy, Michigan
Ark Clinical Research Fountain Valley, 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,
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 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,
Box Hill Hospital Box Hill, Victoria
Bursa Şehir Hastanesi Bursa,
CAMC Health Education and Research Institute Inc Charleston, West Virginia
CEDOES Vitória, Espírito Santo
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, Aquitaine
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 Niao Sung Dist,
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 Toronto,
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,
Edelweiss Medics Kyiv,
Ehime University Hospital Tōon, Ehime
Encore Borland-Groover Clinical Research Jacksonville, Florida
Encore Medical Research Hollywood, Florida
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 - Poruba,
Fiona Stanley Hospital Murdoch, Western Australia
Flinders Medical Centre Bedford Park,
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 Newcastle upon Tyne, England
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,
Fundacion Respirar 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, São Paulo
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,
Glenny Corp. S.A. Buenos Aires,
Gold Coast University Hospital Southport,
Great Lakes Research Institute Southfield, Michigan
Groupe hospitalier mutualiste Les Portes du sud Vénissieux,
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 Hamamatsu, Shizuoka
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 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, Madrid, Comunidad de
Hospital General de Occidente Zapopan,
Hospital Germans Trias I Pujol Badalona, Barcelona [barcelona]
Hospital Infanta Elena Huelva,
Hospital Moinhos de Vento Porto Alegre,
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, Madrid, Comunidad de
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 Porto Alegre,
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 Shi,
Hyogo Prefectural Amagasaki General Medical Center Amagasaki,
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 Bunkyō City,
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Mexico City,
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,
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 Bunkyō City,
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,
Kagawa University Hospital Kita-gun,
Kagoshima University Hospital Kagoshima, Kagoshima,
Kansai Rosai Hospital Amagasaki,
Kantonsspital Olten Olten,
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City,
Karadeniz Teknik Universitesi Tip Fakultesi Trabzon,
Karolinska Universitetssjukhuset Huddinge Huddinge,
Keimyung University Dongsan Hospital Daegu,
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,
Krajská nemocnice Liberec Liberec,
Kumamoto Shinto General Hospital Kumamoto,
Kumamoto University Hospital Kumamoto,
Kurume University Hospital Kurume-shi, Fukuoka
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
Luzern Kantonsspital Lucerne,
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, Styria
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 Nagasaki,
National Hospital Organization Osaka National Hospital 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,
Oita Cardiovascular Hospital Ōita,
Okayama University Hospital Okayama,
Om Research LLC Lancaster, 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,
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 Shatin,
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 Yangsan,
QEII Health Sciences Centre - Victoria General Site Halifax,
Queen Mary Hospital Hong Kong,
Quest Clinical Research San Francisco, California
Rabin Medical Center Petah Tikva,
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, Seoul-teukbyeolsi [Seoul]
Severance Hospital, Yonsei University Health System Seoul, Seoul-teukbyeolsi [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,
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,
Städtisches Klinikum Brandenburg Brandenburg,
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
Teak Research Consults Lawrenceville, Georgia
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,
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,
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, Jiangxi
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,
The Second Xiangya Hospital of Central South University Changsha,
The Third Hospital of Hebei Medical University Shijiazhuang,
The University of Osaka Hospital Suita,
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 Tuenmen,
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,
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,
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, Ontario
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 Gainesville, Florida
University of the Ryukyus Hospital Ginowan,
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,
Xiangya Hospital Central South University Changsha,
Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine Shanghai,
Yamagata University Hospital Yamagata,
Yamanashi Prefectural Central Hospital Yamanashi,
Yeungnam Univeristy Medical Center Nam-gu,
Yokohama City University Hospital Yokohama,
Zhongshan Hospital,Fudan University Shanghai, Shanghai Municipality
Zhoukou Central Hospital Zhoukou,
hospital Italiano de Buenos Aires Ciudad Autónoma de Buenos Aires, Buenos Aires
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.

Contact(s):

Novartis Pharmaceuticals - novartis.email@novartis.com

Principal Investigator:

System ID: NCT06846281

Show full eligibility criteria

Interventions: DRUG: Remibrutinib oral treatment, DRUG: Ocrelizumab

Conditions: Relapsing Multiple Sclerosis

Keywords: MS, RMS, Remibrutinib, LOU064, Ocrelizumab, Age, MRI, T2 lesions, NEDA-3

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Study Locations

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Location	Contacts
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 Miami, Florida	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 Hollywood, 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 Swansea,
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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 Fargo, North 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 Raleigh, North Carolina	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

Contact(s):

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

Principal Investigator:

System ID: NCT07674758

Show full eligibility criteria

Conditions: Cardiomyopathy, Duchenne Muscular Dystrophy (DMD), Becker Muscular Dystrophy, Carrier of Duchenne Muscular Dystrophy

Keywords: Duchenne Muscular Dystrophy, cardiomyopathy, machine learning, cardiac MRI, Biomarker, Outcome measures

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Location	Contacts
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

Contact(s):

Clinical Trials Administrator - clinicaltrials@regeneron.com

Principal Investigator:

System ID: NCT06585410

Show full eligibility criteria

Interventions: DRUG: Cemiplimab, PROCEDURE: Standard of care

Conditions: Cutaneous Squamous Cell Carcinoma (CSCC)

Keywords: Dermato-Oncology, Cemiplimab, Early Stage, Skin Cancer, Non-Melanoma Skin Cancer, UV Skin Damage, Chronic Sun Exposure

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Location	Contacts
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 Phoenix, 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 Brisbane, 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
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)

Contact(s):

Aishwarya Vijendran - guprotocols@alliancenctn.org

Principal Investigator:

System ID: NCT07000084

Show full eligibility criteria

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)

Interventions: 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

Conditions: Stage I Bladder Cancer AJCC v8, Recurrent Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8

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Location	Contacts
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 - (hemoncctrials@geisinger.edu)
Geisinger Medical Center Danville, Pennsylvania	Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania	Site Public Contact - (HemonCCTrials@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)
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)

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

Contact(s):

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

Principal Investigator:

System ID: NCT06372964

Show full eligibility criteria

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.

Interventions: DRUG: Lumateperone, DRUG: Placebo

Conditions: Bipolar Depression

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Location	Contacts
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 San Diego, 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)

Contact(s):

US Biogen Clinical Trial Center - clinicaltrials@biogen.com

Principal Investigator:

System ID: NCT07219043

Show full eligibility criteria

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 within 3 months (preferably within 1 month) prior to randomization and meet adequate criteria (option a preferred over option b):
• Adequate: 10 or more non-sclerotic/evaluable glomeruli and two muscular arteries
• Minimally Adequate: at least 7 non-sclerotic/evaluable glomeruli and one muscular artery * For participants who received any prior treatment for antibody-mediated rejection (AMR), MVI, or TCMR as outlined in Exclusion Criterion 5, the biopsy must be performed at least 6 weeks after completing (or stopping) prior treatment. * Kidney transplant at least 6 months prior to Screening visit (recipients of either living or deceased donors). * DSA: Human leukocyte antigen (HLA) Class I and II antigen-specific DSA-negative (preformed and de novo DSA) as determined by the local laboratory's definition of positivity using single-antigen bead-based assays within 3 months prior to randomization. Key

Exclusion Criteria:

* Transplant: Blood type (ABO)-incompatible transplant. * History of multiple organ transplants including en bloc and dual kidney transplants. * Presence of HLA donor-specific antibodies. * 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. * Prior AMR or TCMR treatment (with the exception of corticosteroids) within 3 months prior to randomization is excluded as listed below. Participants who received any of these treatments between 3 and 6 months prior to randomization must have both a renal biopsy (IC3) and DSA testing at least 6 weeks after completing (or stopping) treatment in order to confirm continuing MVI≥2 and DSA negative status and to determine eligibility:
• Intravenous or subcutaneous immunoglobulin (IVIg or subcutaneous immunoglobulin \[SCIg\]) or plasma exchange (PLEX).
• Complement system inhibitors (e.g., eculizumab).
• Proteasome inhibitors (e.g., bortezomib).
• The anti-interleukin-6 receptor (anti-IL-6R) tocilizumab.
• Any B cell-depleting therapy (including anti-CD20 agents \[e.g., rituximab\]) within 3 months prior to randomization.
• Any other investigational agent within 3 months or 5 half-lives (whichever is longer) of randomization. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Interventions: DRUG: Felzartamab, DRUG: Placebo

Conditions: Microvascular Inflammation

Keywords: Kidney Transplant, Kidney Transplant Rejection

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Location	Contacts
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 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 Brisbane, Queensland
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 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
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

Contact(s):

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

Principal Investigator:

System ID: NCT06706674

Show full eligibility criteria

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.

Interventions: DRUG: Lumateperone high dose, DRUG: Lumateperone low dose, DRUG: Placebo

Conditions: Irritability Associated With Autism Spectrum Disorder

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Location	Contacts
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

Contact(s):

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

Principal Investigator:

System ID: NCT06229210

Show full eligibility criteria

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.

Interventions: DRUG: Lumateperone

Conditions: Schizophrenia, Autism Spectrum Disorder, Bipolar Disorder

Keywords: Pediatric

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Location	Contacts
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
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 San Diego, 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

Contact(s):

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

Principal Investigator:

System ID: NCT06632444

Show full eligibility criteria

Interventions: COMBINATION_PRODUCT: Survodutide, COMBINATION_PRODUCT: Placebo

Conditions: Liver Fibrosis, Metabolic Dysfunction Associated Steatohepatitis (MASH)

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Study Locations

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Location	Contacts
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 Bhubaneswar,	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 Fountain Valley, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Ark Clinical Research Fountain Valley, 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,	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 Fort Sam Houston, 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 County,	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	Boehringer Ingelheim - (australia@bitrialsupport.com)
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 Tōon, Ehime	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)
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 Mayagüez,	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)
Fujian Medical University Union Hospital Fuzhou,	Boehringer Ingelheim - (china@bitrialsupport.com)
Fujita Health University Hospital Toyoake,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Fukuiken Saiseikai Hospital Fukui, Fukui,	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 Scenery Park State College, Pennsylvania	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
General Faculty Hospital, Prague Prague,	Boehringer Ingelheim - (support@bitrialsupport.com)
General Hospital of Ningxia Medical University Ningxia,	Boehringer Ingelheim - (china@bitrialsupport.com)
Gifu Municipal Hospital 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 Côte-d'Or,	Boehringer Ingelheim - (france@bitrialsupport.com)
HRI Medical Center Houston, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Hamamatsu University Hospital Hamamatsu, Shizuoka	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 São Paulo,	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, Madrid, Comunidad de	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 (The First Affiliated Hospital of Hunan Normal University) Changsha,	Boehringer Ingelheim - (china@bitrialsupport.com)
Hyogo College of Medicine Hospital 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)
ISR-GEO Med Res Clin Healthycore Tbilisi,	Boehringer Ingelheim - (sakartvelo@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 Bunkyō City,	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)
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, Kagoshima,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kanazawa University Hospital 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 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 Kurume-shi, Fukuoka	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,	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)
Mercy Medical Center Baltimore, Maryland	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, Niigata	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Ningbo Second Hospital Ningbo,	Boehringer Ingelheim - (china@bitrialsupport.com)
Nippon Medical School Hospital Tokyo,	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 Orlando, 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 Lancaster, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Om Research, LLC Lancaster, 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)
Panthera Biopartners - Enfield Enfield, London,	Boehringer Ingelheim - (unitedkingdom@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)
PingXiang People's Hospital Pingxiang,	Boehringer Ingelheim - (china@bitrialsupport.com)
Pinnacle Clinical Research - Austin Austin, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pinnacle Clinical Research - Corpus Christi Corpus Christi, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pinnacle Clinical Research - San Antonio San Antonio, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pinnacle Clinical Research, LLC Georgetown, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pinnacle Clinical Research, LLC Georgetown, 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 Rosa Isela Luna Ceballos Veracruz,	Boehringer Ingelheim - (mexico@bitrialsupport.com)
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 South Woodville,	Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Queen Elizabeth Hospital Birmingham Birmingham,	Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
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)
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,	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 Matsumoto, Nagano	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)
Suita Hospital Suita-Shi,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
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)
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)
Tampa Bay Medical Research Clearwater, Florida	Boehringer Ingelheim - (unitedstates@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 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)
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,Sun Yat-sen University Guangzhou,	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,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
The University of Tokyo Hospital Bunkyō City,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
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 Kanagawa,	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)
Tweesteden Ziekenhuis, locatie Tilburg Tilburg,	Boehringer Ingelheim - (nederland@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)
UZ Leuven Leuven,
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)
Universitair Ziekenhuis Gent Ghent, Oost-Vlaanderen	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 Bern Bern,	Boehringer Ingelheim - (suisse@bitrialsupport.com)
University Hospital Kyoto Prefectural University of Medicine Kyoto, 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 Alabama at Birmingham Birmingham, Alabama	Boehringer Ingelheim - (unitedstates@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 Florida Gainesville, Florida	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Kansas Medical Center Kansas City, Kansas	Boehringer Ingelheim - (unitedstates@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 Erlangen Erlangen,	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 Tübingen Tübingen,	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, Santa Ana Santa Ana, California
Velocity Clinical Research, Seattle Seattle, Washington	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research, Van Nuys Van Nuys, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research, Waco Waco, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research, Westlake Los Angeles, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research-Chula Vista Chula Vista, California	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research-Dallas-69170 Dallas, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Velocity Clinical Research-Gardena-69773 Gardena, 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)
Waikato Hospital Hamilton,	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)
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)
Yanbian University Hospital Yanji,	Boehringer Ingelheim - (china@bitrialsupport.com)
Yashoda Hospitals - Secunderabad Secunderabad,	Boehringer Ingelheim - (india@bitrialsupport.com)
Yeungnam University Medical Center Deagu,	Boehringer Ingelheim - (namhan@bitrialsupport.com)
Yokohama City University Hospital Yokohama,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Yonsei University Wonju Severance Christian Hospital Wŏnju,	Boehringer Ingelheim - (namhan@bitrialsupport.com)
Yueyang Central Hospital Yueyang,	Boehringer Ingelheim - (china@bitrialsupport.com)
Yuncheng Center Hopsital - West Compus 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 Ciudad Autónoma de Buenos Aires, Buenos Aires	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)

Contact(s):

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

Principal Investigator:

System ID: NCT06998524

Show full eligibility criteria

Interventions: 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

Conditions: 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, Madrid, Comunidad de
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 Kurume-shi, Fukuoka
Manchester Royal Infirmary Manchester,
McGill University Health Center Montreal, Quebec
Nagoya University Hospital Nagoya,
Sahlgrenska Universitetssjukhuset Gothenburg,
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,
University of Florida Gainesville, Florida
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)

Contact(s):

Jennifer Raymond - Jennifer.raymond@vcuhealth.org

Principal Investigator:

System ID: NCT07700225

Show full eligibility criteria

Conditions: Myotonic Dystrophy 1, DM1, Myotonic Dystrophy, Myotonic Muscular Dystrophy, Myotonic Dystrophy Type 1, Myotonic Dystrophy Type-1, Myotonic Dystrophy, Type 1 (DM1)

Keywords: 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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Location	Contacts
Virginia Commonwealth University Richmond, Virginia	Jennifer Raymond - (Jennifer.raymond@vcuhealth.org)

Endocardial Mapping With the CoreMap EP Mapping System (INvENI)

Contact(s):

Jim Foster, SysEng - jfoster@coremapmedical.com

Principal Investigator:

System ID: NCT06529978

Show full eligibility criteria

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

Interventions: DEVICE: CoreMap EP Mapping System Mapping, DEVICE: CoreMap EP Mapping System Map-Guided Ablation

Conditions: Persistent Atrial Fibrillation

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Location	Contacts
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

Contact(s):

Massey CTO CPC Team - MasseyCPC@vcu.edu

Principal Investigator:

System ID: NCT07706192

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Interventions: OTHER: Food Assistance Program, OTHER: Standard of Care

Conditions: Treatment Adherence

Keywords: Treatment Adherence, Food Insecurity, Cancer Patients on Active Treatment

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Location	Contacts
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

Contact(s):

Dyne Clinical Trials - clinicaltrials@dyne-tx.com

Principal Investigator:

System ID: NCT07486934

Show full eligibility criteria

Interventions: DRUG: zeleciment basivarsen (DYNE-101), DRUG: Placebo

Conditions: DM1, Myotonic Dystrophy, Myotonic Dystrophy Type 1 (DM1), Steinert Disease, Steinert

Keywords: 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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Study Locations

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Location	Contacts
AP-HP, Hôpital Raymond-Poincaré Garches,	Pascal Laforet - (pascal.laforet@aphp.fr)
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 Universitario Infanta Sofía San Sebastián de los Reyes, Madrid	Gerardo Gutierrez Gutierrez - (g3.neuro@gmail.com)
IU Health Neuroscience Center Indianapolis, Indiana	Jennifer Terrell - (jkramey@iu.edu)
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 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)
The University of Osaka Hospital Suita,	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)
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 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)
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)

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

Contact(s):

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

Principal Investigator:

System ID: NCT06672549

Show full eligibility criteria

Interventions: DRUG: Orforglipron, DRUG: Placebo

Conditions: Obesity, Overweight

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Location	Contacts
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,
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,
Hackensack University Medical Center Hackensack, New Jersey
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 - PIN Charleston, South Carolina
MultiCare Health System - Mary Bridge Children's Health Center Tacoma, Washington
Nara Prefecture General Medical Center 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, Kyeonggi-do
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
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,
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 Raleigh, North Carolina
Velocity Clinical Research Raleigh, North Carolina
Velocity Clinical Research, Salt Lake City West Jordan, Utah
William A. Shands Hospital at the University of Florida Gainesville, Florida
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials New Haven, Connecticut
Yitzhak Shamir Medical Center Beer Yaakov,

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

Contact(s):

Richard C Webb, PhD - cwebb@rhaeos.com

Principal Investigator:

System ID: NCT07050628

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Interventions: DEVICE: wireless thermal anisotropy measurement device

Conditions: Hydrocephalus

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Location	Contacts
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

Contact(s):

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

Principal Investigator:

System ID: NCT06975111

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Interventions: DRUG: Metformin, DRUG: semaglutide, DRUG: Anti-hypertensives, DRUG: Lipid Lowering Medication, BEHAVIORAL: Life style intervention, DRUG: Fezolinetant, DRUG: Hormonal therapy

Conditions: Menopause, Menopause Hot Flashes, Menopause Related Conditions, Cardiovascular

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Location	Contacts
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)

Contact(s):

Allen Reha - allen.reha@vironexis.com

Principal Investigator:

System ID: NCT07192432

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Interventions: GENETIC: Dose Level 1, VNX-202, GENETIC: Dose Level 2, VNX-202, GENETIC: Dose Level 3, VNX-202, GENETIC: Dose Level 4, VNX-202

Conditions: HER2 Expressing Solid Tumors

Keywords: HER2+ breast cancer, HER2+ gastric cancer, Other HER+ cancer, HER2-low cancer

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Location	Contacts
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)

Contact(s):

Trial Registration Coordinator - clinicaltrials@cslbehring.com

Principal Investigator:

System ID: NCT07224360

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Interventions: BIOLOGICAL: Anumigilimab, DRUG: Placebo

Conditions: Sickle Cell Disease

Keywords: Anemia, Genetic Disorder, Vaso-occlusive Crises

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Location	Contacts
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

Contact(s):

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

Principal Investigator:

System ID: NCT06632457

Show full eligibility criteria

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

Interventions: COMBINATION_PRODUCT: Survodutide, COMBINATION_PRODUCT: Placebo matching survodutide

Conditions: 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 Fountain Valley, 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,	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 Fort Sam Houston, 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 County,	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 Tōon, Ehime	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 Mayagüez,	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 Yunann 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,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Fukuiken Saiseikai Hospital Fukui, Fukui,	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 Faculty Hospital, Prague Prague,	Boehringer Ingelheim - (support@bitrialsupport.com)
General Hospital of Ningxia Medical University Ningxia,	Boehringer Ingelheim - (china@bitrialsupport.com)
Gifu Municipal Hospital 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 Côte-d'Or,	Boehringer Ingelheim - (france@bitrialsupport.com)
Hacettepe Universitesi Tip Fakultesi Ankara,	Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Hamamatsu University Hospital Hamamatsu, Shizuoka	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 São Paulo,	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, Madrid, Comunidad de	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, Madrid, Comunidad de	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 (The First Affiliated Hospital of Hunan Normal University) Changsha,	Boehringer Ingelheim - (china@bitrialsupport.com)
Hyogo College of Medicine Hospital 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)
ISR-GEO Med Res Clin Healthycore Tbilisi,	Boehringer Ingelheim - (sakartvelo@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 Bunkyō City,	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)
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 Bunkyō City,	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, Kagoshima,	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kanazawa University Hospital 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 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 Kurume-shi, Fukuoka	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,	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, Niigata	Boehringer Ingelheim - (nippon@bitrialsupport.com)
Ningbo Second Hospital Ningbo,	Boehringer Ingelheim - (china@bitrialsupport.com)
Nippon Medical School Hospital Tokyo,	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 Orlando, 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,	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 Lancaster, 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 Georgetown, Texas	Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pinnacle Clinical Research, LLC Georgetown, 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 South Woodville,	Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Queen Elizabeth Hospital Birmingham 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,	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 Matsumoto, Nagano	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,	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 Kanagawa,	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, 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)
Waikato Hospital Hamilton,	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

Contact(s):

Clinical Trials Administrator - clinicaltrials@regeneron.com

Principal Investigator:

System ID: NCT06769698

Show full eligibility criteria

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

Interventions: DRUG: FDC fianlimab+cemiplimab, DRUG: Cemiplimab, DRUG: Placebo

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)

Keywords: Recurrent or Metastatic (R/M), Positive for Programmed Death Ligand 1 (PD-L1) Expression, Human Papillomavirus (HPV)

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Study Locations

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Location	Contacts
Asplundh Cancer Pavilion Willow Grove, Pennsylvania
Cairns Hospital Cairns, Queensland
Centre Jean Perrin Clermont-Ferrand,
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, Madrid, Comunidad de
Hospital Universitario Miguel Servet Zaragoza,
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario de Navarra Pamplona, Navarre
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 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

Contact(s):

ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com

Principal Investigator:

System ID: NCT07230288

Show full eligibility criteria

Interventions: DRUG: ABBV-142, DRUG: Placebo for ABBV-142

Conditions: Idiopathic Pulmonary Fibrosis

Keywords: Idiopathic Pulmonary Fibrosis

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Study Locations

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Location	Contacts
Acibadem City Clinic Tokuda University Hospital EAD /ID# 277846 Sofia,
Box Hill Hospital /ID# 278245 Melbourne, Victoria
Caritas-Krankenhaus St. Maria gGmbH /ID# 278138 Donaustauf, Bavaria
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 JM Engelbrecht Trial Site /ID# 278287 Somerset West, Western Cape
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
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
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

Contact(s):

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

Principal Investigator:

System ID: NCT06536049

Show full eligibility criteria

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

Interventions: PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, BIOLOGICAL: Epcoritamab, DRUG: Ibrutinib, PROCEDURE: Positron Emission Tomography

Conditions: Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Recurrent Transformed Non-Hodgkin Lymphoma, Refractory Transformed Non-Hodgkin 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, 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, Recurrent Grade 3b Follicular Lymphoma, Recurrent Primary Mediastinal Large B-Cell Lymphoma, Refractory Grade 3b Follicular Lymphoma, Refractory Primary Mediastinal Large B-Cell Lymphoma

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Study Locations

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Location	Contacts
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)

The HOPE Biobank Resource (BMT CTN 2402 HOPE) (HOPE Resource)

Contact(s):

Megan Scott - mscott@emmes.com

Principal Investigator:

System ID: NCT07227155

Show full eligibility criteria

HCT/GT Inclusion:
• Patients with a diagnosis of Aplastic Anemia (AA), hemoglobinopathies or bone marrow failure from other causes except for malignant diseases will be eligible for enrollment on this protocol:
• AA will be defined as having peripheral blood cytopenias with a hypocellular bone marrow for age and a clinical diagnosis of aplastic anemia as determined by their treating physicians.
• Hemoglobinopathies include sickle cell disease or thalassemia. Patients receiving potentially curative therapy with HCT or GT for hemoglobinopathies will be eligible for this study.
• Individuals with bone marrow failure due to clinical or molecularly diagnosed inherited bone marrow failure, inborn errors of immunity or other cause will be included.
• Patients must receive an HCT or GT for management of their underlying disease. Allogeneic transplants including all conditioning regimens, donors, and GVHD prophylaxis regimens are eligible. This study does not define how the transplant or transplant-supportive care will be performed.
• Patients or their legal guardian must consent to participate in the CIBMTR "Protocol for a Research Database for Hematopoietic Cell Transplantation and Marrow Toxic Injuries" (NCT 1166009) to allow linkage with the longitudinal clinical data collected by CIBMTR.
• All ages minorities, sexes and genders are eligible for the study, but participants must weigh at least 10 kilograms (kg) at the time of study enrollment given the volume and number of blood draws required.
• All participants or parent/legal guardian must sign an informed consent for this study. If there are questions regarding a patient's eligibility for the study, contact the Protocol Team for review and discussion by emailing bmtctn2402@emmes.com. HCT/GT Exclusion
• Patients with aplastic anemia or hemoglobinopathies who are not pursuing allogeneic HCT or GT.
• Active malignancy.
• Hematologic malignancy or therapy for a prior hematologic malignancy in the previous five 5 years.
• Weight ≤ 10.0 kg at time of study enrollment.
• Prior autologous or allogeneic transplant. Related Donor Inclusion: 1\. All related donors for eligible recipients undergoing allogeneic HCT for AA, hemoglobinopathies, or bone marrow failure as defined in the recipient eligibility criteria above are eligible. Note: HCT recipient participants will remain eligible if the related donor declines to participate in the study. Related Donor Exclusion: 1\. Donor weight ≤ 10.0 kg at time of study enrollment

Conditions: Aplastic Anemias, Hemoglobinopathies, Bone Marrow Failure

Keywords: Biorepository, Biospecimens, Allogenic Transplant, Gene Therapy

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Study Locations

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Location	Contacts
Baylor College of Medicine Houston, Texas	Deb Dowlin - (deborah.dowlin@bcm.edu)
Children's Healthcare of Atlanta Atlanta, Georgia	Judson Russell - (judson.russell@choa.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin	Kira Mielke - (kmielke@mcw.edu)
City of Hope Duarte, California	Miranda Lee - (mirlee@coh.org)
Duke University Medical Center Durham, North Carolina	Quinna Lawson - (quinna.marshburn@duke.edu)
Fred Hutchinson Cancer Center Seattle, Washington	Sheri Ballard - (sballard@fredhutch.org)
Lurie Children's Hospital of Chicago Chicago, Illinois	Morgan Kearney - (mkearney@luriechildrens.org)
Memorial Sloan Kettering Cancer Center New York, New York	Alyssa Kamrowski - (kamrowsa@mskcc.org)
Oregon Health and Science University Portland, Oregon	Denise Lackey - (lackey@ohsu.edu)
St. Louis Children's St Louis, Missouri	Lissy Keller - (kellerl@wustl.edu)
University of Florida Gainesville, Florida	Giselle Morre-Higgs - (mooregj@ufl.edu)
Vanderbilt University Medical Center Nashville, Tennessee	Melanie Hallowell Hallowell - (melanie.hallowell@vumc.org)
Virginia Commonwealth University Richmond, Virginia	Mehreen Qureshi - (mehreen.qureshi@vcuhealth.org)
Washington University St Louis, Missouri	Maggie Nash - (nashm@wustl.edu)

Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII

Contact(s):

Black Diamond Therapeutics Clinical Trial Navigation Service - blackdiamondtx@careboxhealth.com

Principal Investigator:

System ID: NCT07326566

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Interventions: DRUG: silevertinib in combination with temozolomide, DRUG: temozolomide (TMZ)

Conditions: Glioma, Brain Cancer, Glioblastoma (GBM), Newly Diagnosed Glioblastoma, GBM, Glioblastoma Multiforme (GBM), Central Nervous System Diseases

Keywords: EGFR, Glioblastoma, Unmethylated, Unmethylated MGMT promoter, Newly Diagnosed, temozolomide, Temodar, silevertinib, BDTX-1535, EGFR alterations, epidermal growth factor receptor, EGFRvIII, epidermal growth factor receptor (EGFR)

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Location	Contacts
Atlantic Health Summit, New Jersey	Samantha Caulfield, RN - (Samantha.caulfield@atlantichealth.org)
Beth Israel Deaconess Medical Center Boston, Massachusetts	Ka-Wai Ho, MD - (Kho5@bidmc.harvard.edu)
Cedars-Sinai Medical Center Los Angeles, California	Shannon Cyhan, RN, BSN, CCRC - (shannon.cyhan@cshs.org)
Columbia University Irving Medical Center New York, New York	Research Nurse Navigator - (Cancerclinicaltrials@cumc.columbia.edu)
Dana Farber Cancer Institute Boston, Massachusetts	Amanda Dresser - (Amanda_Dresser@dfci.harvard.edu)
Henry Ford Cancer- Detroit Detroit, Michigan	Meghan Gauronskas, RN - (mgauron1@hfhs.org) Nicole Beck - (nbeck2@hfhs.org)
Highlands Oncology Group Springdale, Arkansas	Renee Feast - (sfarrow@hogonc.com)
Huntsman Cancer Institute, University of Utah Salt Lake City, Utah	Rachel Kingsford - (rachel.kingsford@hci.utah.edu)
Inova Schar Cancer Institute Fairfax, Virginia	Stephanie Van Bebber - (Stephanie.VanBebber@inova.org)
John Theurer Cancer Center at Hackensack University Medical Center Hackensack, New Jersey	Oncology Clinical Research Referral Oﬃce - (OncologyResearchReferral@hmhn.org)
Johns Hopkins Sibley Memorial Hospital Washington D.C., District of Columbia	Solmaz Sahebjam, MD - (ssahebj1@jh.edu)
Johns Hopkins Sidney Kimmel Cancer Center - Baltimore Baltimore, Maryland	Solmaz Sahebjam, MD - (ssahebj1@jh.edu)
Massachusetts General Hospital Boston, Massachusetts	Isabel Arrillaga-Romany - (iarrillaga@mgh.harvard.edu)
Miami Cancer Institute Miami, Florida	Anais Vega - (Anais.Vega@baptisthealth.net)
Moffitt Cancer Center Tampa, Florida	Carie Bliss - (Carie.Bliss@moffitt.org)
Montefiore Medical Center The Bronx, New York	Yoko Eng - (yeng@montefiore.org)
Northwell Health Center for Advanced Medicine - Brain Tumor Center Lake Success, New York	Center for Advanced Medicine - Brain Tumor Center - (neurosurgeryresearch@northwell.edu)
Ohio State University Columbus, Ohio	Jake Lanning - (Jake.Lanning@osumc.edu)
Prisma Health Greenville, South Carolina	Kim Williams - (Kim.Williams3@Prismahealth.org)
Rutgers Cancer Institute New Brunswick, New Jersey	Xiaoru Chen - (xc194@cinj.rutgers.edu)
Stanford University Palo Alto, California	Kelly Tanner - (secure-sci-cto-neuro-crcs@lists.stanford.edu)
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center Philadelphia, Pennsylvania	Community Research Operations & Enrollment - (ONCTrialNow@jefferson.edu)
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania	Linda Elias - (eliaslj@upmc.edu)
University of Alabama at Birmingham O'Neal Comprehensive Cancer Center Birmingham, Alabama	Staci Hankins - (sshea@uabmc.edu)
University of Nebraska Medical Center Omaha, Nebraska	Michaela Savine - (misavine@unmc.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia	Keara Mackey - (mackeyka@vcu.edu)
Washington University School of Medicine Siteman Cancer Center St Louis, Missouri	Kelsey Etter - (etter@wustl.edu)
Yale Cancer Center New Haven, Connecticut	Amy Rodrigues - (amy.rodrigues@yale.edu)

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