Clinical trials: Acute Hepatitis
Acute Hepatitis C, Human Immunodeficiency Virus
Dutch Acute HCV in HIV Study (DAHHS-2): Grazoprevir/Elbasvir for Acute HCV
New and recently EMA/FDA approved direct acting antiviral (DAA) combination therapies cure 95% or more of the patients chronically infected with HCV genotype 1 and 4.
- Conditions
- Acute Hepatitis C, Human Immunodeficiency Virus, Hepatitis C
- Trial name
- DAHHS-2 (NCT02600325)
- Testing
- Grazoprevir/Elbasvir 100mg/50mg
- Where
- 9 sites in Belgium, Netherlands
- Volunteers
- 80 people
- Sponsor
- Erasmus Medical Center
Severe Acute Decompensated Alcoholic Hepatitis
Efficacy and Safety of Orally Administered DS102 in Patients With Acute Alcoholic Hepatitis
The purpose of this randomised, double-blind, placebo-controlled, phase II study is to assess the efficacy and safety of orally administered DS102 in adult patients with acute decompensated alcoholic hepatitis
- Trial name
- NCT03452540
- Testing
- 1000mg DS102 (BID)
- Where
- 8 sites in United States, Georgia
- Volunteers
- 9 people
- Sponsor
- Afimmune
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.
Acute Liver Failure, Acute Liver Injury
Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury
This Phase 2a clinical study is designed to provide data on OCR-002 in patients with acute liver failure/acute liver injury (ALF/ALI) in regard to: safety and tolerability; metabolism of the compound to glutamine and…
- Trial name
- STOP-ALF (NCT01548690)
- Testing
- Ornithine Phenylacetate
- Where
- 11 sites in United States
- Volunteers
- 47 people
- Sponsor
- William Lee
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
Acute Alcoholic Hepatitis, Chemical and Drug Induced Liver Injury
Digoxin In Treatment of Alcohol Associated Hepatitis
Prospective, single center, open label, randomized controlled trial to explore whether digoxin treatment affects cytokine levels as biomarkers of inflammation in patients with acute alcohol associated hepatitis, digoxin…
- Conditions
- Acute Alcoholic Hepatitis, Chemical and Drug Induced Liver Injury, Alcohol-Induced Disorders, Steatohepatitis Caused by Ingestible Alcohol
- Trial name
- DIGIT-AlcHep (NCT05014087)
- Testing
- Intravenous digoxin
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Yale University
Acute Hepatitis C, HIV
Short Duration Therapy of Acute Hepatitis C Genotypes 1 or 4
The purpose of this study is to assess the rate of sustained virological response (SVR) 12 weeks after 8-week oral treatment with grazoprevir 100mg/elbasvir 50mg (MRK-combo) in patients with acute hepatitis C genotype1 or 4.
- Trial name
- SAHIV (NCT02886624)
- Testing
- Grazoprevir/Elbasvir
- Where
- 6 sites in France
- Volunteers
- 30 people
- Sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Hepatitis C Infection With HIV Co-Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV)…
- Trial name
- NCT02457611
- Testing
- LDV/SOF
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 26 people
- Sponsor
- Gilead Sciences
Acute Alcoholic Hepatitis
Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD in Subjects w/ AILD
The primary objective of the study is to evaluate safety and efficacy of ELAD with respect to overall survival of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) through at least Study Day 91.
- Trial name
- NCT02612428
- Testing
- ELAD System, Standard of Care (Control)
- Where
- 44 sites in United States, Austria and 4 more
- Volunteers
- 151 people
- Sponsor
- Vital Therapies, Inc.
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
Hepatitis C, Human Immunodeficiency Virus
Treatment of Acute Hepatitis C Virus in HIV Co-Infection
This study is designed to test the hypothesis that treatment of hepatitis C virus (HCV) infection during the first 6 months after acquiring HCV among people who already have pre-existing HIV infection will result in improved…
- Conditions
- Hepatitis C, Human Immunodeficiency Virus, HIV Infections
- Trial name
- NCT00845676
- Testing
- Pegylated interferon alfa-2a + Ribavirin
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of California, San Francisco
Hepatitis C Infection, HIV Infection
Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection
The purpose of this study was to assess the efficacy of a fixed dose combination (FDC) of glecaprevir/pibrentasvir (G/P) given for 4 weeks for treatment of acute hepatitis C (HCV), with or without HIV-1 coinfection.
- Trial name
- PURGE-C (NCT04042740)
- Testing
- Glecaprevir/Pibrentasvir (G/P)
- Where
- 12 sites in United States, Brazil
- Volunteers
- 45 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
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.
HIV-1 Infection, Hepatitis
Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection
Early identification of acute HCV infection is essential to prevent chronic infections and the long-term liver disease complications that may occur.
- Trial name
- SWIFT-C (NCT02128217)
- Testing
- Sofosbuvir, Ribavirin, Ledipasvir/Sofosbuvir
- Where
- 12 sites in United States
- Volunteers
- 44 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Hepatitis B, Chronic
A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both
This open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus…
- Trial name
- NCT00962871
- Testing
- peginterferon alfa-2a [Pegasys], tenofovir
- Where
- 6 sites in United States, New Zealand and 2 more
- Volunteers
- 30 people
- Sponsor
- Hoffmann-La Roche
Alcoholic Hepatitis
A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe…
- Trial name
- AH (NCT03432260)
- Testing
- DUR-928 30 mg, DUR-928 90 mg, DUR-928 150 mg
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- Durect
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
Cirrhosis, End Stage Liver Disease
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies).
- Conditions
- Cirrhosis, End Stage Liver Disease, Acute Kidney Injury, Liver Transplant; Complications
- Trial name
- MHALT (NCT03534141)
- Testing
- Esophageal cooling/warming device, Mild hypothermia, Normothermia
- Where
- 3 sites in United States
- Volunteers
- 175 people
- Sponsor
- University of California, San Francisco
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
Hepatitis C Virus (HCV)
Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)
HCV infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and…
- Trial name
- NCT04903626
- Testing
- Glecaprevir/Pibrentasvir (GLE/PIB)
- Where
- 70 sites in United States, Australia and 6 more
- Volunteers
- 286 people
- Sponsor
- AbbVie