StudyFinder
Search Results Within Category "Digestive Health and Liver Disease"
28 Study Matches
Fecal Microbiota Transplantation in Cirrhosis and Hepatic Encephalopathy
Brown, Diandra - diandra.brown@vcuhealth.org
Bajaj, Jasmohan
NCT03796598
HM20015322
drug: Fmt
Diseases of Digestive System (520-579)
Semaglutide vs. Placebo in Subjects with NASH and Compensated Liver Cirrhosis
Grubb, Emily - Emily.Grubb@vcuhealth.org
Sanyal, Arun, J
NCT03987451
HM20016500
drug: Semaglutide
Diseases of Digestive System (520-579)
ENhancing Recovery in CHildren Undergoing Surgery for IBD (ENRICH-US) (ENRICH-US)
Han, Jinfeng - jinfeng.han@vcuhealth.org
Sulkowski, Jason, P
NCT04060303
HM20018603
Modality: No vcuhs billing
Diseases of Digestive System (520-579)
Efficacy, Safety and Tolerability of Two Does of NGM282 for the Treatment of NASH (ALPINE2/3)
Grubb, Emily - Emily.Grubb@vcuhealth.org
Siddiqui, Mohammad, S
NCT03912532
HM20015256
drug: Rosuvastatin calcium,
drug: Ngm282
Diseases of Digestive System (520-579)
Non-Invasive Quantification of Liver Health in NASH (N-QUAN) (N-QUAN)
Boyett, Sherry - sherry.boyett@vcuhealth.org
Sanyal, Arun, J
NCT04054310
HM20017712
Diseases of Digestive System (520-579)
Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV
Jennifer Price, MD, PhD - jennifer.price@ucsf.edu
Sterling, Richard, K
NCT04795219
HM20021371
Inclusion Criteria:
* 18 years of age or older
* HIV-1, documented historically by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA.
* On ART for 6 months prior to screening with HIV RNA \<200 copies/mL at entry
Exclusion Criteria:
* Evidence of current or prior chronic HBV, as marked by the presence of HBsAg in serum at any time prior to enrollment (patients with isolated antibody to hepatitis B core antigen, anti-HBc total, are not excluded)
* Evidence of recent or current HCV as marked by the presence of anti-HCV antibody with detectable HCV RNA in serum within 3 years prior to enrollment. Participants with anti-HCV antibody positivity who have undetectable HCV RNA 3 years prior to enrollment (either due to spontaneous clearance or clearance with treatment) will be eligible to participate if HCV RNA at entry remains undetected.
* Known other chronic liver disease, including but not limited to alpha-1- antitrypsin deficiency, Wilson's disease, hemochromatosis, polycystic liver disease, autoimmune hepatitis, and primary biliary cholangitis. Note that alcohol-related liver disease is not exclusionary.
* Disseminated or advanced malignancy
* Pregnancy
* Concomitant severe underlying systemic illness that, in the opinion of the investigator, would interfere with completion of study procedures
* Inability to complete a FibroScan® VCTE scan:
* Use of implantable active medical device such as a pacemaker or defibrillator
* Wound care near the application site of the FibroScan®
* Pregnancy
* Ascites (fluid in the abdominal area)
* Unable or unwilling to complete the FibroScan® without sedation or unable to lie still for sufficient duration to complete the exam
* Any other condition that, in the opinion of the investigator, would impede compliance or hinder completion of study procedures
* Inability to complete the informed consent process or comply with study procedures NAFLD, NAFLD-HIV, Hiv
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer (AIM-NIVO)
McFadden, Faith - mcfaddenfr@vcu.edu
Poklepovic, Andrew, S
NCT03816345
HM20022009
Inclusion Criteria:
* Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1/PD-L1 inhibitor has been approved in the adjuvant setting. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab is Food and Drug Administration (FDA)-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer, hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible but must follow standard response criteria. Additional tumor types may be eligible on a case by case basis upon discussion with principal investigator (PI). Patients enrolling on the trial for adjuvant use will be restricted to those with histology for which a PD-1/PD-L1 inhibitor has been approved in the adjuvant setting including but not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancer
* Patients who have previously received other forms of immunotherapy (high-dose \[HD\] IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy for at least 4 weeks before nivolumab administration. Patients who have received prior anti-CTLA4 will be allowed and the washout period is 6 weeks
* Age \>= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky \>= 60)
* Life expectancy of greater than 12 weeks
* Leukocytes \>= 1,000/mcL
* Absolute neutrophil count \>= 500/mcL
* Platelets \>= 50,000/mcL
* Total bilirubin =\< 2 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5 x institutional ULN or =\< 8 x institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values
* Creatinine ULN OR glomerular filtration rate (GFR) \>= 30 mL/min (if using the Cockcroft-Gault formula)
* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial
* If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated
* If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load
* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the investigator favors participation in the clinical trial
* The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL. These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
* Ability to understand and the willingness to sign a written informed consent document
* Patients with more than one autoimmune disease are eligible. The treating physician would determine which autoimmune disease is dominant and the patient would be treated under that specific cohort
Exclusion Criteria:
* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy (RT) is permitted (2 week washout from start of treatment), if all of the following criteria are met:
* Repeat imaging demonstrates no new sites of bone metastases
* The lesion being considered for palliative radiation is not a target lesion
* Patients with prior therapy with an anti-PD-1 or anti-PD-L1
* Patients with prior allogeneic hematologic transplant
* Patients who are receiving any other anticancer investigational agents
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements PROCEDURE: Biospecimen Collection, BIOLOGICAL: Nivolumab
Autoimmune Disease, Crohn Disease, Dermatomyositis, Hematopoietic and Lymphoid Cell Neoplasm, Inflammatory Bowel Disease, Malignant Solid Neoplasm, Multiple Sclerosis, Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, Sjogren Syndrome, Systemic Lupus Erythematosus, Systemic Scleroderma, Ulcerative Colitis
Nonalcoholic Fatty Liver Disease in HIV Database
Tinsay A Woreta, MD, MPH - tworeta1@jhmi.edu
Sterling, Richard, K
NCT05023044
HM20023554
Inclusion Criteria:
* Documented HIV infection
* ≥18 of age at time of initial screening
* HIV suppression with HIV RNA \<200 copies/ml on stable ART for ≥ 6 months and no change in ART class for ≥ 3 months, prior to enrollment
* Participants must meet at least one of the following inclusion criteria:
* Histologically confirmed NAFLD \[defined as NAFL (\>5% steatosis, with or without lobular or portal inflammation), borderline NASH or definitive NASH\] within 6 months prior to screening (per local pathology report)
* Liver stiffness measurement (LSM) ≥6 kPa from FibroScan exam performed during screening or within 12 months prior to screening and a diagnosis of NAFLD based on clinical and imaging (FibroScan CAP≥263 dB/m, ultrasound, CT or MRI) diagnosis at any time
* LSM ≥8 kPa from FibroScan exam performed during screening or within 12 months prior to screening, in the absence of CAP ≥263 dB/m
* Able to provide written informed consent to part
* Willingness to be in the study for 1 or more years
* Provision of written informed consent
Exclusion Criteria:
* Positive hepatitis B surface antigen
* Evidence of recent or current hepatitis C virus (HCV) as marked by the presence of anti-HCV antibody with detectable HCV RNA in serum within 3 years prior to enrollment. Participants with anti-HCV antibody positivity who have undetectable HCV RNA 3 years prior to enrollment (either due to spontaneous clearance or clearance with treatment) will be eligible to participate if HCV RNA at entry remains undetected
* Significant alcohol consumption (≥ 3 drinks daily on average in men and ≥ 2 drinks daily on average in women)
* Evidence of other causes of chronic liver disease
* History of prolonged (\> 1 month) total parenteral nutrition within a 6-month period before liver biopsy or before baseline FibroScan VCTE exam
* Short bowel syndrome
* History of biliopancreatic diversion
* History of bariatric surgery within 2 years of enrollment (participants expecting to undergo bariatric surgery can be enrolled prior to the procedure)
* Solid organ transplant recipients
* Other condition that is likely to interfere with study follow-up NAFLD, NASH - Nonalcoholic Steatohepatitis, Hiv
Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis (EMMPACT)
Margaret Koziel, MD - clinicaltrials@axcellahealth.com
Siddiqui, Mohammad, S
NCT04880187
HM20022234
Inclusion Criteria:
• Willing to participate in the study and provide written informed consent.
• Male and female adults aged > 18 years.
• Must have NASH and fibrosis on a liver biopsy sample
• If a historical liver biopsy is used for Screening, obtained within 6 months prior to Screening;
• Subjects may have a diagnosis of T2DM
Exclusion Criteria:
• History or presence of liver disease (other than NAFLD or NASH)
• History or presence of cirrhosis and/or history or presence of hepatic decompensation
Drug: AXA1125, Drug: Placebo
Non Alcoholic Steatohepatitis (NASH)
Steatosis, Lobular inflammation, Ballooning, Liver biopsy, Liver fat, Liver stiffness, NASH, Aminio Acids, Fibrosis
An Integrative Model for Palliative Care in End-Stage Liver Disease
Joel Wedd, MD, MPH - joel.wedd@vcuhealth.org
NCT05238779
Inclusion Criteria:
Primary participant:
• admission for decompensated cirrhosis, age ? 18
• willingness to sign consent
• able to read and understand English
• presence of decompensated cirrhosis with portal hypertension (jaundice, ascites, HE, hepatohydrothorax, AKI, HRS and/or variceal bleeding) or HCC Caregiver:
• identified as the primary caregiver of the participant
• age ? 18
• willingness to sign consent
• able to read and understand English
Exclusion Criteria:
Primary participant:
• prior liver transplant
• lack of capacity to provide informed consent (in the judgement of the investigator)
• already in receipt of palliative or hospice care
• those who are likely to receive a LT during the index admission Caregiver: ? none
Other: Standard of care including palliative care
End Stage Liver Disease
Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon
ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com
Chaudary, Nauman
NCT05069597
HM20025086
Inclusion Criteria:
• Previous diagnosis of cystic fibrosis (CF) or chronic pancreatitis (CP).
• Previous diagnosis of exocrine pancreatic insufficiency (EPI) that is currently clinically controlled.
• Total Symptom Score (TSS) < 1.8 on Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) at Screening.
Exclusion Criteria:
• Malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with EPI symptom assessment.
Drug: CREON
Cystic Fibrosis, Chronic Pancreatitis
Cystic Fibrosis, Chronic Pancreatitis, Exocrine Pancreatic Insufficiency, Creon, Pancrelipase
Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
Sherry Boyett, RN - sherry.boyett@vcuhealth.org
NCT05424003
Inclusion Criteria:
* Male or female age 18-75 years who received LT for any indication (i.e. NASH, hepatitis C, alcohol-induced cirrhosis, autoimmune hepatitis, etc.)
* Liver transplant surgery within 8-24 weeks prior to randomization
* Fasting glucose \> 125 mg/dL or presence of diabetes (HbA1c≥6.5% or use of diabetes medications) or pre-diabetes (HbA1c \>5.7%)
* Ability to provide informed consent
* Discharged from the hospital following LT surgery
* Tolerating diet
* Normal graft function\* (determined by treating hepatologist/surgeon based on clinical status and hepatic panel)
* Stable immunosuppression according the VCU (Virginia Commonwealth University) post-LT protocols \*\* (i.e. calcineurin inhibitors + mycophenolate)
* Eligible female patients will be (1) non-pregnant, evidenced by a negative urine pregnancy test, (2) non-lactating, (3)surgically sterile or post-menopausal, or they will agree to continue to use an accepted method of birth control during the study
Exclusion Criteria:
* BMI≤ 27kg/m2
* GFR (Glomerular Filtration Rate) ≤ 25 ml/min/1.73m2
* Type 1 autoimmune diabetes (by anti-GAD (glutamic acid decarboxylase) or history of ketoacidosis)
* History of gastroparesis
* Familial or personal history of medullary thyroid cancer or MEN (Multiple Endocrine Neoplasia) 2
* History of pancreatitis
* History of active malignancy post- LT with the exception of non-melanoma skin cancers
* History of uncontrolled or unstable diabetic retinopathy or maculopathy
* Acute cellular rejection
* Hepatic artery thrombosis
* Medical non-compliance
* Active treatment with GLP (glucagon-like peptide)-1RA (receptor agonist) or SGLT (sodium-glucose cotransporter)-2 inhibitors at time of screening
* History of hypersensitivity to semaglutide or its excipients
* Women who are nursing, pregnant, or planning to become pregnant during the study, or are not using adequate contraceptive measures DRUG: Semaglutide Pen Injector, DRUG: Placebo
NAFLD
Liver Transplant
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH (Symmetry)
Lester Scholtes, Rebecca - Rebecca.Lester@vcuhealth.org
Asgharpour, Amon
NCT05039450
HM20023488
drug: Efruxifermin
Diseases of Digestive System (520-579)
The Impact of Sarcopenia in Patients with Cirrhosis
Evans, Marie-Claire - marieclaire.evans@vcuhealth.org
Siddiqui, Mohammad, S
18741
HM20019626
Diseases of Digestive System (520-579)
Efficacy of EsoGuard on Samples Collected Using EsoCheck Versus EGD for the Diagnosis of BE
Coleman, PARIS - paris.coleman@vcuhealth.org
Smallfield, George, B
NCT04293458
HM20018839
Diseases of Digestive System (520-579)
A Study to Assess the Efficacy and Safety of VK2809 for 52 Weeks in Subjects With Biopsy Proven NASH (VOYAGE)
Hurst, Caitlin - hurstc3@vcu.edu
Sanyal, Arun, J
NCT04173065
HM20018948
drug: Vk2809
Diseases of Digestive System (520-579)
A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)
Lindemuth, Margaret (Maggie) - margaret.lindemuth@vcuhealth.org
Siddiqui, Mohammad, S
NCT04104321
HM20018490
drug: Aramchol
Diseases of Digestive System (520-579)
Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4) (ALPINE4)
Lindemuth, Margaret (Maggie) - margaret.lindemuth@vcuhealth.org
Siddiqui, Mohammad, S
NCT04210245
HM20019792
drug: Ngm282
Diseases of Digestive System (520-579)
Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis with Fibrosis
Patel, Falgun - falgun.patel@vcuhealth.org
Siddiqui, Mohammad, S
NCT05011305
HM20021644
drug: Saroglitazar magnesium
Diseases of Digestive System (520-579)
Phase 2B, Randomized, Double-Blind, Placebo-Controlled - Safety/ Efficacy of Efruxifermin - NASH
Edwards, Megan, C - megan.edwards@vcuhealth.org
Siddiqui, Mohammad, S
NCT04767529
HM20021459
drug: Efruxifermin
Diseases of Digestive System (520-579)
A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury
Clinical Operations - clinicaltrials@ocelotbio.com
NCT05309200
Inclusion Criteria:
• Signed informed consent form (ICF) by participant or their legal/authorized representatives.
• Diagnosed with decompensated cirrhosis with ascites.
• Receiving albumin and has had appropriate diuretic withdrawal for at least 2 days prior to randomization into the study.
• Beta-blockers should be discontinued 48 hours prior to randomization, unless doctor deems necessary for appropriate medical treatment.
• No sustained improvement in renal function after both diuretic withdrawal and plasma volume expansion with albumin.
• Female participants must have a negative pregnancy test prior to randomization and agree to avoid becoming pregnant during the study and for 30 days after the end of treatment. Male participants must agree to use 2 effective contraceptive methods during the study and up to 30 days after the end of treatment.
Exclusion Criteria:
• Serum Creatinine >3.8 mg/dL.
• Large volume paracentesis (LVP ≥6L) within 4 days of randomization.
• Pulse oximeter reading of <90% on 2L or less.
• Sepsis and/or uncontrolled bacterial infection.
• Experienced shock within 72 hrs prior to screening.
• Model for End-Stage Liver Disease (MELD) score >35.
• Hypertension with a Systolic BP > 140 mmHg and/ or a Diastolic BP >100 mmHg.
• Treated with or exposed to nephrotoxic agents or has had exposure to radiographic contrast agents within 72 hrs prior to screening.
• Has superimposed acute liver injury due to drugs, or toxins except for acute alcoholic hepatitis.
• Proteinuria greater than 500 mg/dL.
• Impaired cardiac function as evidenced by symptoms consistent with New York Heart Association Classification Class 2 or worse.
• Received Renal Replacement Therapy (RRT) within 4 weeks of randomization.
• Has had a Trans Jugular Intrahepatic Porto-systemic shunt (TIPS).
• Pregnant or breastfeeding.
• Diagnosed with a malignancy within the past 5 years.
• History or current evidence of any condition (COVID-19 positive with respiratory/cardiac complications), therapy or laboratory abnormality that might confound the results of the study, interfere with the participation for the full duration of the study, or is not in the best interest to participate in the opinion of the investigator.
• Participated in a study of an investigational medical product or device within the last 8 weeks preceding screening.
• Experienced a major blood loss (≥500 mL) within the last 4 weeks prior to screening.
• Is stuporous or comatose at screening (West Haven scores III and IV). exhibiting bradycardia.
Drug: OCE-205, Drug: Placebo
Cirrhosis, Ascites, Hepatorenal Syndrome, Acute Kidney Injury
HRS-AKI
Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease (IMPACT)
Jasmohan S Bajaj, MD - jasmohan.bajaj@vcuhealth.org
NCT05548452
Inclusion Criteria:
-\>18 years of age
* Advanced liver disease
* Able to give written, informed consent
* Alcohol as a cause of advanced liver disease
* Continued sustained drinking
* Having previously declined a referral to traditional AUD therapy services or having failed such treatments
Exclusion Criteria:
* Lack of sustained drinking
* Recent or current alcoholic hepatitis
* Alcohol withdrawal symptoms
* Clinically significant use of illicit drugs
* Uncontrolled mood disorders or primary psychotic conditions
* MELD score\>17
* Unclear diagnosis of chronic liver disease
* Current hepatic encephalopathy on lactulose and/or rifaximin
* WBC count\<1000
* Non-elective hospitalization within last month
* on dialysis
* known untreated, in-situ luminal GI cancers
* chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease or microscopic colitis, eosinophilic gastroenteritis and celiac disease)
* Dysphagia within 2 weeks
* History of aspiration, gastroparesis, intestinal obstruction
* Ongoing absorbable antibiotic use
* Severe anaphylactic food allergy
* allergy to ingredients Generally Recognized As Safe in the G3 capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil)
* Adverse event attributable to prior IMT
* ASA Class IV or V
* Pregnant or nursing patients
* acute illness or fever on the day of planned FMT
* Immunosuppression
* Other conditions which make patients are poor candidate for this study per investigator judgement DRUG: Intestinal Microbiota Transplant (IMT) Capsules, DRUG: Placebo Capsules
Liver Disease, Alcohol-Related, Cirrhosis, Alcohol Use Disorder
Intestinal Microbiota Transplant, Alcohol Use Disorder, Cirrhosis, Chronic Liver Disease
Liver Cirrhosis Network Cohort Study (LCN-C)
Crystal K Santillanes, MS - lcn@northwestern.edu
NCT05740358
Inclusion Criteria:
* Age ≥ 18 years
* Willing to provide samples at baseline
* Cirrhosis
Where Cirrhosis is defined as:
• At least one liver biopsy within 5 years prior to consent showing either: a) Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis OR
• At least 2 of the following:
• Evidence on imaging: Nodular liver with either splenomegaly or recanalized umbilical vein within the past year 2. Liver stiffness: VCTE within one year prior to consent or during Screening ≥12.5 kPa or MRE within one year prior to consent or during Screening ≥5 kPa 3. Evidence of varices demonstrated on imaging or endoscopy within 3 years prior to consent or during Screening 4. Either: FIB-4\>2.67 or platelets \<150/mL within 6 months prior to consent or during Screening 5. \>5 years METAVIR stage 4 fibrosis or Ishak stage 5-6
Exclusion Criteria:
* Known and documented prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma
* Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence
* Known prior solid organ transplant or bone marrow transplant
* Current participation in active medication treatment trials at the time of consent for LCN Cohort Study
* Prisoners or individuals with more than 180 days incarceration pending due to difficulty with visits
* Bariatric surgery in the last 180 days prior to consent
* Known history of fontan procedure-associated liver disease (FALD)
* Known current medical or psychiatric conditions which, in the opinion of the investigator, would make the participant unsuitable for the study or interfere with or prevent follow-up per protocol
* Current liver-unrelated end-stage organ failures (Dialysis, stage 3-4 congestive heart failure (CHF), current chronic obstructive pulmonary disease (COPD) on home oxygen, current known active malignancy besides non-melanomatous skin cancer or carcinoma in situ)
* Documented history of acute alcohol-associated hepatitis (according to NIAAA criteria as described in the MOP) in the 180 days prior to consent
* Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis)
* In patients with primary sclerosing cholangitis (PSC): Current active cholangitis with 90 days prior to consent
* Documented cardiac cirrhosis
* Known recent (within the last 365 days) or present hepatic decompensation with ascites/hydrothorax (including trace ascites discovered at screening not requiring intervention), hepatic encephalopathy or variceal bleeding. If a patient has had a history of decompensation, they must have been off any medications to treat decompensation for at least 365 days. Refer to the MOP for clarifying details on evaluating eligibility for patients with a history of prior decompensation.
* Known or documented habitual non-adherence to previous research studies or medical procedures or unwillingness to adhere to protocol (e.g., unwilling to obtain consent or samples)
* Current model for end-stage liver disease (MELD-Na) cut off ≥ 15\*
* Current Child-Turcotte-Pugh (CTP) B or C\*
* Current known Hepatitis C Virus (HCV) without sustained virologic response (SVR)
* Current known quantifiable Hepatitis B Virus (HBV) viral DNA on therapy with ongoing adherence on suppressive therapy\*
* In patients with autoimmune hepatitis: serum aspartate aminotransferase (AST) \> 2X upper limit of normal (ULN) within 90 days prior to consent or during Screening\*
* In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 90 days prior to consent or during Screening\*
* Indicates an exclusion criterion that may depend on laboratory results and other clinical assessments to be ordered during Screening after confirming the participant is otherwise eligible. If the test was performed as standard-of-care in the 90 days prior to consent, it does not need to be re-done for eligibility. Cirrhosis, Cirrhosis, Liver, Cirrhosis Early, Cirrhosis Due to Hepatitis B, Cirrhosis Advanced, Cirrhosis Infectious, Cirrhosis Alcoholic, Cirrhosis, Biliary, Cirrhosis Cryptogenic, Cirrhosis Due to Hepatitis C, Cirrhosis Due to Primary Sclerosing Cholangitis, Autoimmune Hepatitis
Cirrhosis, Liver, Nonalcoholic Fatty Liver Disease, NASH, Nonalcoholic steatohepatitis
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury (NEUTRALIZE-AKI)
Mohamed Zidan, MD - mzidan@seastarmed.com
NCT05758077
Inclusion Criteria:
* Admitted to an ICU requiring CKRT:
• Must have AKI stage 2 or greater at the time of CKRT initiation.
• Must have been on CKRT for at least 12 hours but no greater than 48 hours at the time of enrollment. * At least 18 years of age but not older than 80 at the time of enrollment. * One additional life-threatening organ dysfunction present. * Acceptable vascular access for CKRT to include adequate lumen size and length of catheters. * Initial (non-binding) commitment to maintaining current level of care for at least 96 hours. * C-Reactive Protein \>3.5 mg/dl.
Exclusion Criteria:
* Not expected to survive next 24 hours.
* Anticipated transition to comfort measures or hospice in next 4 days.
* Terminal condition whereby the patient is not expected to survive 28 days or any condition in which therapy is regarded as futile by the PI.
* Advanced malignancy which is actively being treated or may be treated with palliative chemotherapy or radiation.
* ICU hospitalization \> 14 days during this hospital admission (to include days spent at ICU of an outside hospital) at the time of screening.
* Active COVID-19 infection with a primary admission diagnosis of COVID-19.
* Chronic use of ventricular assist devices.
* ESRD requiring chronic kidney replacement therapy.
* History of CKD (greater than Stage 3).
* AKI stage 0 or stage 1 at the time of CKRT initiation.
* Non-ATN AKI diagnosis. We intend on relying on local nephrology subspecialty expertise to reasonably exclude non-ATN diagnoses based on clinical suspicions combined with prespecified objective criteria. If there is a reasonable suspicion that the subject has non-ATN AKI based on this, they will be excluded from the trial.
* Acute coronary syndromes, acute stroke, or acute major vascular compromise requiring medical or surgical interventions within 48 hours of randomization.
* Active hemorrhage requiring blood transfusions at the time of screening.
* Acute on Chronic Liver Failure.
* Suspicion of hepato-renal syndrome.
* Presence of any solid organ transplant at any time prior to admission.
* Severe burns with a modified Baux score \> 100 (%TBSA+Age+17 for Inhalation Injury).
* Bone marrow transplant within the last year.
* Chronic immunosuppression with an average of \>20 mg/day of prednisone or other steroid sparing immunosuppressants for the past 30 days prior to hospital admission.
* Individuals who have a history of primary or secondary immune disorders including, but not limited to, HIV or AIDS.
* Dry weight of \>150kg.
* Platelet count \<15,000/mm3.
* Patient is a prisoner or member of a vulnerable population.
* Patient is pregnant or breast feeding.
* Concurrent enrollment in another interventional clinical trial for an investigational drug or device.
* Need for plasmapheresis. DEVICE: Selective Cytopheretic Device, OTHER: Standard of Care
Acute Kidney Injury
continuous kidney replacement therapy, continuous renal replacement therapy, acute kidney injury, organ failure, inflammation, dialysis, acute tubular necrosis
Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (LCN RESCU)
Crystal Santillanes, MS - lcn@northwestern.edu
NCT05832229
Inclusion Criteria:
• Age 18-75 years
• Cirrhosis due to nonalcoholic steatohepatitis, alcohol-associated liver disease, or chronic viral hepatitis (treated hepatitis B virus or hepatitis C virus)
• Clinical diagnosis of cirrhosis as defined investigator confirmation and the following:
• At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR
• At least 2 of the following: i. Evidence on imaging: Nodular liver with either splenomegaly or recanalized umbilical vein within the past 48 weeks ii. Liver stiffness: vibration-controlled transient elastography within 48 weeks prior to consent or during Screening ≥15 kilopascal or magnetic resonance elastography within 48 weeks prior to consent or during Screening ≥5 kilopascal iii. Evidence of varices demonstrated on imaging or endoscopy within 3 years prior to consent or during Screening iv. Either: Fibrosis-4\>2.67 or platelets \<150/mL within 6 months prior to consent or during Screening
• Two measures of vibration-controlled transient elastography: one at screening and one at the randomization study visit, meeting the following criteria:
• The first measure must be ≥ 15 kilopascal.
• The two measures must be at least 2 hours apart and no more than 60 days apart from one another.
• The mean of two measurements must be ≥ 15 kilopascal.
• Additionally, both screening and open-label dispense liver stiffness measures must be ≤50 kPa
• Compensated defined by:
• Absence of ascites/hydrothorax, hepatic encephalopathy or variceal bleeding currently or in the last 48 weeks, as determined clinically by investigator.
• If prior history of decompensation, must be without current symptoms of decompensation and no longer requiring treatment of complications for the last 48 weeks, including the use of diuretics for the treatment of ascites, and/or rifaximin or lactulose for the treatment of hepatic encephalopathy. Use of non-selective beta blockers will be allowed.
• Child-Pugh score \<8
• Provision of written informed consent.
Exclusion Criteria:
• Currently on a statin or any statin exposure within 24 weeks prior to consent.
• Known indication for statin therapy, defined as:
• Prior peripheral vascular, cardiovascular or cerebrovascular event for which statins are indicated for secondary prevention, OR
• Documented familial hypercholesterolemia, heterozygous familial hypercholesterolemia, OR
• Fasting LDL-C ≥ 190 mg/dL
• Myocardial infarction, Unstable angina, transient ischemic events, or stroke within 24 weeks of screening.
• Alcohol Use Disorder Identification Test (AUDIT) total score of ≥8 at screening.
• Patients with limitations in attending study visits.
• Prisoners.
• Known prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma.
• Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence.
• Current (in past 24 weeks prior to consenting) use of medications known to cause hepatic fibrogenesis or confound endpoint assessment, defined as:
• amiodarone
• methotrexate
• warfarin
• Current (in past 24 weeks prior to consenting) use of medications which may increase risk for rosuvastatin-related myositis or DILI, defined as:
• fenofibrate
• erythromycin
• gemfibrozil
• niacin (500 mg or more)
• HIV protease inhibitors (darunivar, indinavir, nelfinavir, amprenavir) in patients of East Asian descent
• colchicine
• cyclosporin
• Additional medications that will be excluded: atazanavir/ritonavir capmatinib darolutamide dasabuvir/ombitasvir/paritaprevir/ritonavir ledipasvir/sofosbuvir elbasvir/grazoprevir erythromycin glecaprevir/pibrentasvir lopinavir/ritonavir regorafenib ritonavir, in any combination simeprevir sofbuvir/velpatasvir/voxilaprevir sofosbuvir/velpatasvir tafamidis teriflunomide \*If exposure was for 7 or less days for one of these medications can consider enrollment after 28 days from final dose.
• Presence of portal or hepatic vein thrombosis
• Diagnosis of untreated hypothyroidism or on unstable treatment regimen for hypothyroidism
• Receiving an elemental diet or parenteral nutrition
• Chronic pancreatitis or pancreatic insufficiency
• Etiology of cirrhosis other than ALD, NAFLD, or viral hepatitis (excluded diagnoses include cryptogenic immune-mediated such as AIH, PSC and PBC, cardiac cirrhosis or Fontan-associated liver disease, A1AT, Wilson's disease, etc.)
• Conditions which may confound study outcome:
• Unstable or active inflammatory bowel disease
• Active infection
• Any malignant disease (other than squamous or basal cell carcinoma of the skin) within previous 3 years
• Prior solid organ or hematopoietic cell transplant
• Bariatric surgery in the last 24 weeks prior to consent or planned bariatric surgery within the next 96 weeks
• Current liver-unrelated end-stage organ failures such as end-stage renal disease on dialysis, stage 3-4 congestive heart failure (CHF), current chronic obstructive pulmonary disease (COPD) on home oxygen.
• Known current medical or psychiatric conditions which, in the opinion of the investigator, would make the participant unsuitable for the study for safety reasons or interfere with or prevent adherence to the protocol.
• The following laboratory abnormalities within 90 days of screening:
• Hemoglobin \<10 g/dL
• Albumin \<3.0 g/dL
• Prolonged international normalized ratio (INR) \>1.5
• Total bilirubin ≥ 2.0 mg/dl (unless due to Gilbert's syndrome or hemolysis as denoted by normal direct bilirubin fraction)
• Direct bilirubin ≥ 0.9
• Uncontrolled diabetes (HbA1c ≥ 9.5%) within past 90 days.
• Kidney function abnormalities including:
• Dialysis
• Baseline eGFR \< 30 cc/min with CKD-Epi equation
• Known nephrotic proteinuria, defined as 3g or greater of protein in 24-hour urine collection
• Recent (within 48 weeks) or present hepatic decompensation with ascites/hydrothorax, hepatic encephalopathy or variceal bleeding
• Untreated chronic hepatitis B or C infection
• HCV eligible for enrollment if HCV RNA negative at baseline or documentation of prior SVR12
• HBV eligible if an HBV DNA \<100 IU/mL within the last 48 weeks and on treatment
• Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 200 U/L, or alkaline phosphatase (ALP) ≥ 300 within the past 24 weeks.
• Documented history of intolerance to statins
• Serious comorbid medical disease which in the investigator's opinion renders a life-expectancy less than 96 weeks
• Active illicit substance use (other than THC), including inhaled or injected drugs, in the 24 weeks prior to screening
• Pregnancy, planned pregnancy or breastfeeding
• Current participation in active medication treatment trials (within 24 weeks prior to randomization) or planned participation in active medication treatment trials simultaneous to participation in present trial.
• Significant existing muscle pain or tenderness or prior history of myasthenia gravis as determined by a site physician.
• Failure or inability to provide informed consent.
DRUG: Rosuvastatin
Cirrhosis, Cirrhosis, Liver, Cirrhosis Early, Cirrhosis Due to Hepatitis B, Cirrhosis Advanced, Cirrhosis Infectious, Cirrhosis Alcoholic, Cirrhosis Due to Hepatitis C
Cirrhosis, Liver, Nonalcoholic Fatty Liver Disease
Oral Health In Cirrhosis of the Liver (ORACLE) (ORACLE)
Jasmohan Bajaj, MD - jasmohan.bajaj@vcuhealth.org
NCT06052150
Inclusion Criteria:
* Age\>18 years
* Cirrhosis confirmed (liver biopsy, signs of current or prior decompensation, varices in patients with chronic liver disease, nodular liver on imaging, AST\>ALT and platelet count \>150K in patients with chronic liver disease, ultrasound, or MR elastography suggestive of cirrhosis).
* Willing and able to give consent
Exclusion Criteria:
* Unclear diagnosis of cirrhosis
* Unable or unwilling to consent
* Edentulous
* Prior organ transplant
* On anticoagulant therapy PROCEDURE: Dental exam and periodontal cleaning if needed
Cirrhosis, Periodontal Diseases
National Liver Cancer Screening Trial (TRACER)
Amit Singal, MD, MS - Amit.Singal@UTSouthwestern.edu
NCT06084234
Inclusion Criteria:
Patient must meet all of the following inclusion criteria:
• Adult patients ages 18-85 with cirrhosis from any etiology or with chronic hepatitis B with a PAGE-B score greater than 9 within 12 months of enrollment
• Patient is eligible for HCC surveillance according to treating physician or by the site investigator
• Able to provide informed consent
• Life expectancy \>6 months (after consent) as determined by the treating provider or site investigator
Exclusion Criteria:
Patient will be excluded for any of the following exclusion criteria:
• Child Pugh C cirrhosis
• History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma
• History of solid nodule on baseline ultrasound (i.e., lesion 1cm or greater) within 9 months prior to consent without subsequent diagnostic CT/MRI demonstrating benign nature)
• AFP \>20 ng/mL within 6 months prior to consent, in the absence of a contrast-enhanced CT or MRI within 6 months of AFP (before or after) level demonstrating lack of suspicious liver lesions
• Newly diagnosed LR-3 greater than or equal to 1 cm within 6 months prior to consent
• History of LR-4, LR-5, or LR-M on multi-phase CT or contrast-enhanced MRI within 6 months prior to consent
• Presence of another active cancer besides non-melanomatous skin cancer or indolent cancer under active surveillance (e.g., prostate cancer or renal cell carcinoma) within the 2 years prior to consent
• Patient's provider is planning to use MRI- or CT- based surveillance moving forward
• History of a transjugular intrahepatic portosystemic shunt (TIPS)
• History of Fontan associated liver disease or cardiac cirrhosis
• History of solid organ transplantation
• Actively listed for liver transplantation
• Diagnosis of alcohol-associated hepatitis within 3 months prior to consent
• Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis)
• In patients with primary sclerosing cholangitis (PSC): Current active cholangitis within 90 days prior to consent
• Known or documented habitual non-adherence to previous research studies or medical procedures or unwillingness to adhere to protocol (e.g., unwilling to obtain consent or samples)
• In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 60 days prior to consent
• Known pregnancy at consent
• Active warfarin use
DIAGNOSTIC_TEST: GALAD, DIAGNOSTIC_TEST: Liver Ultrasound with or without AFP
Carcinoma, Hepatocellular, Liver Cancer, Liver Cirrhosis, Hepatitis B
Hepatocellular carcinoma surveillance, GALAD, Alpha Fetoprotein
miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial
Joshua Carlson - jcarlson@miromatrix.com
NCT06285253
Inclusion Criteria:
• 18 years to 80 years old at the time of signing the informed consent
• Subject must:
• be deemed competent to consent by an independent qualified practitioner, or
• have consent given by a Legally Authorized Representative
• Subject should be in the intensive care unit
• Be diagnosed with 4.1. Acute Liver Failure defined as:
• INR ≥ 2.0, and
• Hepatic Encephalopathy Grade II-III (West Haven Criteria), and
• Less than 4 weeks (28 days) of disease duration 4.2. Severe Acute Alcohol-Associated Hepatitis as defined as:
• Hepatic Encephalopathy Grade I-III (West Haven Criteria), and
• Model for End-Stage Liver Disease (MELD) Score ≥ 20, and
• INR ≥ 2.0, and
• No overt evidence of cirrhosis 4.3. Acute on Chronic Liver Failure:
• Hepatic Encephalopathy Grade I-III (West Haven Criteria), and
• Model for End-Stage Liver Disease (MELD) Score ≥ 20, and
• INR ≥ 2.0, 5\. Subject is not a candidate for liver transplant and will not become a candidate in the event of worsening conditions. Exclusion Criteria
• Grade IV West Haven Encephalopathy Criteria
• Previous liver transplant
• Currently requires chronic hemodialysis (CRRT or other forms of continuous renal replacement are allowed).
• Uncontrolled documented infection, hypotension, or refractory shock. This is defined as a need for a single vasopressor, or combination of vasopressors, that exceed a norepinephrine equivalent of 0.5 mcg/kg/min.
• Liver injury due to trauma
• Any current liver cancer
• Currently on medications with a narrow therapeutic index
• Platelet count \< 40,000 μL
• If the subject is intubated and has an acute lung injury
• Experiencing a bleeding event, defined as:
• Active gastrointestinal or other overt bleeding event, or
• Hemoglobin drop \> 3g/dL within the past 24 hours, or
• Received ≥ 3 units of red blood cell transfusion within the past 24 hours
• Female that is currently pregnant, planning to be pregnant, or currently breastfeeding
• Refusal to receive blood products
COMBINATION_PRODUCT: miroliverELAP treatment
Acute Liver Failure, Acute Liver Injury, Drug Induced, Acute on Chronic Liver Failure (ACLF), Acute Alcoholic Hepatitis
Acute liver failure, Extracorporeal liver assist, Bioengineered liver