Clinical trials: Alcohol-Related Liver Disease
Alcoholic Cirrhosis
Alcohol Biomarker Study
Objective: To validate ethyl glucuronide in scalp hair, fingernail and urine as a biomarker for alcohol use in patients with alcoholic cirrhosis.
- Trial name
- NCT04363424
- Where
- Netherlands
- Volunteers
- 191 people
- Sponsor
- Maastricht University Medical Center
Alcoholic Hepatitis
Protective Immune Mechanisms in Alcoholic Hepatitis
The purpose of this study is to investigate the production, effects and interactions of the hepato-protective cytokine interleukine (IL)-22 in patients with alcoholic hepatitis.
- Trial name
- AHIL (NCT01918462)
- Where
- Denmark
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Binge Drinking, Liver Injury
Metabolic Changes in Healthy Subjects with Acute Binge Drink
The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drinking on liver function, liver fat content, and lipid metabolism in healthy young subjects.
- Conditions
- Binge Drinking, Liver Injury, Hepatic Steatosis
- Trial name
- MeABD (NCT06298318)
- Testing
- Vodka, water
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Zhejiang Chinese Medical University
Alcoholic Liver Disease, Severe Alcoholic Hepatitis
Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease
Alcoholic hepatitis carries a risk of high mortality at short term, especially in its severe form. Its diagnosis is confirmed by liver biopsy.
- Conditions
- Alcoholic Liver Disease, Severe Alcoholic Hepatitis, Alcoholic Cirrhosis
- Trial name
- COMADHAA (NCT04106518)
- Where
- 9 sites in France
- Volunteers
- 447 people
- Sponsor
- University Hospital, Lille
Alcoholic Hepatitis
Fecal Microbial Transplantation in Severe Alcoholic Hepatitis
1. A subtype of Alcoholic hepatitis (AH), named severe alcoholic hepatitis (SAH) is associated with high short-term mortality (J Hepatol, 2019) 2.
- Trial name
- FMTH7 (NCT04758806)
- Testing
- Fecal microbial transplantation
- Where
- Slovakia
- Volunteers
- 50 people
- Sponsor
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
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
Alcoholic Hepatitis
Pegfilgrastim in Patients With Alcoholic Hepatitis
This is a multi-center, prospective, randomized trial of standard of care vs. standard of care + pegfilgrastim (Neulasta®) among patients with a clinical diagnosis of alcoholic hepatitis and DF≥32.
- Trial name
- NCT02776059
- Testing
- Standard of care + pegfiltrastim, Standard of care
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Timothy Morgan, MD
Hepatitis
Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
The primary purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90 in participants with severe alcohol-associated hepatitis (AH) with pre-treatment…
- Trial name
- NCT07428538
- Testing
- Larsucosterol
- Where
- 92 sites in United States
- Volunteers
- 350 people
- Sponsor
- Bausch Health Americas, Inc.
Liver Diseases, Alcoholic
Using Addiction Comprehensive Health Enhancement Support System (ACHESS) in an Alcoholic Liver Disease Population
This is a pilot study examining whether an evidence-based recovery support smartphone application, the Addiction Comprehensive Health Enhancement Support System (A-CHESS), can decrease alcohol recidivism in a previously unstudied…
- Trial name
- NCT03388320
- Testing
- A-CHESS
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- New York Presbyterian Hospital
Hepatitis B Virus, HIV
Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa
This is a prospective HIV cohort that aims to establish causes of liver disease among HIV-infected individuals in Zambia, including viral hepatitis and alcohol.
- Conditions
- Hepatitis B Virus, HIV, Antiretroviral Therapy, Africa
- Trial name
- NCT02060162
- Testing
- Standard of care
- Where
- Zambia
- Volunteers
- 897 people
- Sponsor
- University of Alabama at Birmingham
Liver Diseases, Alcoholic, Alcohol Use Disorder
Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial
To evaluate the efficacy of systematically offering newly diagnosed ALD patients to AUD treatment, in the hepatology clinic, on alcohol abstinence after 6 months.
- Conditions
- Liver Diseases, Alcoholic, Alcohol Use Disorder, Treatment Adherence, Alcoholism
- Trial name
- NCT06493773
- Testing
- Offer of specialized alcohol use disorder treatment in the hepatology clinic
- Where
- Denmark
- Volunteers
- 221 people
- Sponsor
- Zealand University Hospital
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
Alcohol Use Disorder, Liver Transplant; Complications
Safety of Acamprosate in Treating Alcohol Use Disorder in the Post Liver Transplant Populations
Acamprosate for alcohol use disorder may benefit liver transplant (LT) recipients with alcohol-associated liver disease (ALD), yet data on feasibility and safety in LT recipients are lacking.
- Trial name
- NCT06471686
- Testing
- Acamprosate
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Southern California
Alcoholic Liver Cirrhosis
Dose Finding Study to Assess Safety and Efficacy of Stem Cells in Liver Cirrhosis
This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in various parameters will be observed over 2 years.
- Trial name
- NCT01591200
- Testing
- Allogeneic Mesenchymal Stem Cells
- Where
- 10 sites in India
- Volunteers
- 40 people
- Sponsor
- Stempeutics Research Pvt Ltd
Alcohol-related Liver Disease, Liver Diseases
Enhancing Alcohol Treatment Engagement in Associated Liver Disease (ALD) Patients
The purpose of this trial is to see if providing patients with alcohol-related liver disease with tailored alcohol use treatment options will increase engagement with treatment and correct possible misconceptions.
- Trial name
- ENGAGE-ALD (NCT06269510)
- Testing
- ENGAGE-ALD Application (APP), Treatment Facilitation bundle, Enhanced Usual Care
- Where
- United States
- Volunteers
- 268 people
- Sponsor
- Henry Ford Health System
Alcoholic Hepatitis
Pentoxyphilline Versus Fecal Microbiota Therapy in Severe Alcoholic Hepatitis
Treatment for severe alcoholic hepatitis patients not eligible for steroid therapy is a dilemma. Pentoxyfilline has been shown to have no improvement in outcomes as per current studies and liver transplantation is with great risk…
- Trial name
- NCT02458079
- Testing
- Pentoxiphylline, Stool microbiota transplantation
- Where
- India
- Volunteers
- 32 people
- Sponsor
- Institute of Liver and Biliary Sciences, India
Alcoholic Liver Disease
Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease
Background/Aims: The investigators explored the therapeutic effects of probiotics in patients with AH. Methods: Between September 2010 and April 2012, the investigators conducted a 7-day, double-controlled, randomized…
- Trial name
- EPALD (NCT01501162)
- Testing
- hepatitis, alcohol, probiotics
- Where
- South Korea
- Volunteers
- 130 people
- Sponsor
- Chuncheon Sacred Heart Hospital
Hepatitis, Alcoholic
Pentoxifylline for Acute Alcoholic Hepatitis (AAH)
The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable.
- Trial name
- NCT00205049
- Testing
- pentoxifylline
- Volunteers
- 4 people
- Sponsor
- University of Wisconsin, Madison
Diabetes, Chronic Kidney Diseases
Benchtop NMR Spectroscopy for Assessment of Clinical Human Pathologies (BRANCH-P STUDY)
This research programme seeks to combine the resources of NHS primary care, with the leading spectroscopic work in low-magnetic fields of the Wilson Group (Nottingham Trent University) to demonstrate the potential for benchtop…
- Conditions
- Diabetes, Chronic Kidney Diseases, Cancer, Bowel Disease
- Trial name
- BRANCH-P (NCT05473325)
- Where
- United Kingdom
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Willows Health
Severe Alcoholic Hepatitis
Evaluation of HepQuant SHUNT to Assess Liver Disease; Substudy Within GS-US-416-2124
This clinical investigation is a substudy within GS-US-416-2124, IND 129570, which is A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination with Prednisolone versus…
- Trial name
- NCT03087968
- Testing
- GS-4997, Prednisolone, HepQuant SHUNT Test
- Where
- 13 sites in United States
- Sponsor
- HepQuant, LLC