Clinical trials: Alcohol Liver Disease
Severe Acute Alcoholic Hepatitis
To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure
The purpose of this study is to determine if treatment with the ELAD System is safe and effective in subjects with severe acute alcoholic hepatitis and Lille score failures (Lille score >0.45).
- Trial name
- NCT01829347
- Testing
- ELAD, Standard of Care treatment
- Where
- 39 sites in United States, Germany and 2 more
- Volunteers
- 18 people
- Sponsor
- Vital Therapies, Inc.
Hepatitis C, Alcohol Abuse
Web-based Intervention to Reduce Alcohol Use in Veterans With Hepatitis C
Many people who are infected with Hepatitis C misuse alcohol, which is even more dangerous for them than it is for a non-infected person.
- Trial name
- NCT01707030
- Testing
- Web-Based Brief Alcohol Intervention, Usual Care
- Where
- 2 sites in United States
- Volunteers
- 138 people
- Sponsor
- VA Office of Research and Development
Alcoholic Hepatitis
A Safety and Efficacy Study of Mycophenolate Mofetil and Rilonacept in Patients With Alcoholic Hepatitis
This clinical trial will test two new therapies for the treatment of alcoholic hepatitis. Patients who "respond" to the current standard of care therapy for alcoholic hepatitis(corticosteroid/prednisolone therapy) after 1 week of…
- Trial name
- NCT01903798
- Testing
- Mycophenolate mofetil, Prednisolone, Rilonacept
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Southern California Institute for Research and Education
Hepatitis C, Alcohol Use Disorders
Baclofen to Reduce Alcohol Use in Veterans With HCV
Hepatitis C (HCV) is the most common blood born virus in the United States, affecting 1.8% of the general population and more than 5% of Veterans using VA facilities.
- Trial name
- BRAC (NCT01008280)
- Testing
- baclofen
- Where
- 4 sites in United States
- Volunteers
- 180 people
- Sponsor
- VA Office of Research and Development
Alcoholic Hepatitis
Alcoholic Hepatitis Network Observational Study
The purpose of this research study is to create a clinical database and bio-repository. To do this, we will obtain blood, urine, saliva, and stool samples (e.g., biological samples) and personal health information from you to use…
- Trial name
- NCT03850899
- Where
- 9 sites in United States
- Volunteers
- 1,133 people, healthy volunteers welcome
- Sponsor
- Indiana University
Acute Alcoholic Hepatitis
Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis
This study will compare two different treatments of acute alcoholic hepatitis. The current standard of care is treatment with corticosteroids (methylprednisolone).
- Trial name
- NCT01809132
- Testing
- Anakinra, Pentoxifylline, Zinc Sulfate
- Where
- 4 sites in United States
- Volunteers
- 104 people
- Sponsor
- Mack Mitchell
Liver Disease, Alcoholic
Effects of SAMe in Patients With Alcoholic Liver Disease
Prior studies in animal models have established that the pathogenesis of alcoholic liver disease (ALD) is regulated in part by the effects of chronic alcohol abuse on hepatic methionine metabolism.
- Trial name
- NCT00573313
- Testing
- S-adenosylmethionine
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Alcohol-related Liver Disease
Acamprosate Safe to Use in Individuals With Liver Disease.
Is acamprosate safe to use in individuals with liver disease.
- Trial name
- NCT04287920
- Testing
- Acomprosate
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Mayo Clinic
Patient Adherence, Chronic Hepatitis C, Alcohol-related Disorders
VBMI to Increase Treatment Completion With MK-MK-5172/MK-8742 Among Veterans With Active Substance Use Disorders Genotype 1 Chronic Hepatitis C
This study implement a values-based motivational interviewing (VBMI) intervention to promote treatment completion with fixed dose combination (FDC) MK-5172/MK-8742 x 12 weeks among 30 Veterans with substance use disorder (SUD)…
- Trial name
- VBMI SUD/HCV (NCT02823457)
- Testing
- VBMI
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- G.V. (Sonny) Montgomery VA Medical Center
Acute Alcoholic Hepatitis
Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure
The primary objective of the study is to evaluate safety and efficacy of ELAD® with respect to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) up to at least Study Day…
- Trial name
- NCT01471028
- Testing
- ELAD treatment, Standard of care (Control)
- Where
- 45 sites in United States, Australia and 2 more
- Volunteers
- 203 people
- Sponsor
- Vital Therapies, Inc.
Alcoholic Hepatitis
Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)
The main purpose of this study is to test the effectiveness of Obeticholic Acid when used in patients with moderately severe alcoholic hepatitis.
- Trial name
- TREAT (NCT02039219)
- Testing
- 10 mg Obeticholic Acid (OCA)
- Where
- 4 sites in United States
- Volunteers
- 19 people
- Sponsor
- Naga P. Chalasani
Alcoholic Hepatitis
Study of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Steroid Therapy
The main purpose of the study is to test if taking a study drug called emricasan (also known as IDN-6556 and PF-03491390) will affect overall patient survival after one month of treatment.
- Trial name
- AH (NCT01912404)
- Testing
- IDN-6556
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Hepatitis, Alcoholic
Safety and Efficacy of IMM 124-E for Patients With Severe Alcoholic Hepatitis
Hypothesis: Oral administration of hyperimmune bovine colostrum enriched with anti-LPS antibodies will reduce endotoxemia, and improve pathophysiological and clinical parameters related to severe alcoholic hepatitis (SAH).
- Trial name
- TREAT (NCT01968382)
- Testing
- IMM 124-E (Hyperimmune Bovine Colostrum)
- Where
- 3 sites in United States
- Volunteers
- 57 people
- Sponsor
- Virginia Commonwealth University
Alcoholic Hepatitis (AH)
Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)
The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).
- Trial name
- NCT02854631
- Testing
- Selonsertib, Prednisolone
- Where
- 44 sites in United States, Austria and 5 more
- Volunteers
- 104 people
- Sponsor
- Gilead Sciences
Acute Alcoholic Hepatitis
Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis
This study is being done to find out whether a diet supplemented with a probiotic nutrient can improve alcoholic hepatitis and gut complications compared to routine standard care.
- Trial name
- NTAH-Mod (NCT01922895)
- Testing
- Lactobacillus Rhamnosus GG
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- University of Texas Southwestern Medical Center
Lysosomal Acid Lipase Deficiency
Clinical Study In Infants With Rapidly Progressive Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, study of sebelipase alfa in infants with rapidly progressive lysosomal acid lipase deficiency (LAL-D). Eligible participants received once-weekly infusions of sebelipase alfa for up to 3 years.
- Trial name
- NCT02193867
- Testing
- Sebelipase Alfa
- Where
- 5 sites in United States, Finland and 2 more
- Volunteers
- 10 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hepatorenal Syndrome
A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin
This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.
- Trial name
- NCT01143246
- Testing
- Terlipressin
- Where
- 73 sites in United States, Canada
- Volunteers
- 196 people
- Sponsor
- Mallinckrodt
Alcoholic Hepatitis
Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis
This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term…
- Trial name
- AlcHepNet (NCT04072822)
- Testing
- Anakinra and Zinc, Prednisone
- Where
- 10 sites in United States
- Volunteers
- 147 people
- Sponsor
- Indiana University
Acute-On-Chronic Liver Failure
TAK-242 in Patients With Acute Alcoholic Hepatitis
A phase 2a double-blind, randomized, placebo-controlled, multicenter, proof-of-concept study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of TAK-242 in subjects with acute decompensation of…
- Trial name
- NCT04620148
- Testing
- TAK-242
- Where
- 3 sites in United Kingdom
- Volunteers
- 4 people
- Sponsor
- Akaza Bioscience Ltd
Alcoholic Hepatitis
IL-1 Signal Inhibition in Alcoholic Hepatitis
Alcoholic hepatitis (AH) is a florid presentation of alcoholic liver disease characterized by liver failure in the context of recent and heavy alcohol consumption.
- Trial name
- ISAIAH (NCT03775109)
- Testing
- Canakinumab 150mg/ml solution for injection
- Where
- 16 sites in United Kingdom
- Volunteers
- 55 people
- Sponsor
- Imperial College London