Ongoing Clinical Trials for Alcoholic Hepatitis
There are currently 4 clinical trials investigating new treatments for alcoholic hepatitis, a serious liver condition caused by excessive alcohol consumption. These studies are taking place across several European countries including Austria, France, Germany, Portugal, and Spain, testing various medications aimed at reducing liver inflammation and improving patient outcomes.
Clinical trial locations
- Austria
- France
- Germany
- Portugal
- Spain
Study on the Effects of Alpha-1 Antitrypsin and Prednisolone in Patients with Severe Alcohol-Related Hepatitis
This trial is investigating Alpha-1 Antitrypsin as a treatment for severe alcohol-related hepatitis. The study focuses on reducing inflammation in the liver through weekly intravenous infusions of this protein over a four-week period.
Main inclusion criteria: Participants must be at least 18 years old with severe alcohol-associated hepatitis, determined by a Maddrey’s discriminant function score of 32 or higher. They must have consumed more than 80 grams of alcohol daily for men, or more than 60 grams for women, over the past three months. Participants should be outpatients or hospitalized patients not in intensive care, and must be able to speak and read German. Women of childbearing potential must use effective contraception and have a negative pregnancy test.
Main exclusion criteria: The study excludes pregnant or breastfeeding individuals, those with severe allergies to the study medication, people with other serious health conditions that might interfere with the study, current participants in other clinical trials, individuals with substance abuse issues that could affect results, those who have received interfering medications, and anyone unable to comply with study procedures.
Trial focus: The trial aims to evaluate how effectively Alpha-1 Antitrypsin reduces inflammation in patients with severe alcohol-associated hepatitis. Researchers will monitor participants through regular blood tests and assessments over approximately 90 days to measure the treatment’s impact on inflammation and other health markers.
Investigational drug: Alpha-1 Antitrypsin is a protein administered intravenously at a dose of 120 mg per kilogram of body weight. It works by inhibiting enzymes that cause tissue damage, thereby reducing inflammation in the liver.
Study on the Effects of INT-787 for Patients with Severe Alcohol-Associated Hepatitis
This double-blind trial is testing INT-787, an experimental oral capsule, in patients with severe alcohol-associated hepatitis. The study will evaluate the medication’s effectiveness in managing disease progression over a treatment period of up to 28 days.
Main inclusion criteria: Participants must be between 18 and 65 years old with a clinical diagnosis of severe alcohol-associated hepatitis. This includes a history of heavy drinking for at least 6 months with less than 60 days of abstinence before jaundice onset, serum total bilirubin greater than 3.0 mg/dL, AST of 50 U/L or higher, an AST/ALT ratio of 1.5 or more, jaundice onset within the last 8 weeks, a Modified Maddrey’s Discriminant Function score between 32 and 70, and a MELD score between 18 and 25. Participants must use effective birth control methods and agree to join an alcohol use disorder program.
Main exclusion criteria: The trial excludes individuals with other serious liver diseases besides severe alcohol-associated hepatitis, pregnant or breastfeeding women, those with severe allergic reaction histories, current participants in other clinical trials, individuals with mental health conditions affecting study participation, those with non-alcohol drug abuse history, and people with medical conditions that could interfere with the study or pose health risks.
Trial focus: The study aims to determine if INT-787 can slow or halt disease progression in severe alcohol-associated hepatitis. Researchers will assess safety, tolerability, and efficacy using the Lille score on Day 7 as a key measurement, along with monitoring throughout the treatment period.
Investigational drug: INT-787 is an experimental oral medication being tested in Phase 2a trials. It is believed to work by modulating specific pathways involved in liver inflammation and damage.
Study on the Effectiveness of N-Acetylcysteine and Methylprednisolone for Patients with Severe Acute Alcoholic Hepatitis
This trial is evaluating a combination treatment using methylprednisolone, a steroid that reduces inflammation, and N-acetylcysteine, which helps protect the liver. The study aims to determine how effectively this combination reduces mortality risk in patients with severe acute alcoholic hepatitis.
Main inclusion criteria: Both males and females aged 18 to 75 can participate. Participants must have a diagnosis of acute alcoholic hepatitis following specific guidelines or confirmed by liver tissue examination, with a Maddrey Score of 32 or higher. They must provide written informed consent to participate.
Main exclusion criteria: The study excludes patients without a diagnosis of severe alcoholic hepatitis, those under 18 or over 65 years old, vulnerable populations unable to give informed consent, pregnant or breastfeeding women, individuals with other serious health conditions that might interfere with treatment, and current participants in other clinical trials.
Trial focus: The study will monitor patients over time to assess one-month mortality rates as the primary outcome, with additional assessments at three and six months. Researchers will also evaluate liver complications, infections, kidney problems, tolerance to N-acetylcysteine treatment, and the relationship between the Lille index at day 7 and treatment response.
Investigational drugs: Methylprednisolone is a corticosteroid that suppresses immune response and reduces liver inflammation. N-acetylcysteine is an antioxidant and hepatoprotective agent that helps protect the liver by replenishing glutathione levels. Both medications are administered intravenously.
Study on the Safety and Effects of Resatorvid and Filgrastim for Patients with Severe Alcoholic Hepatitis and Acute-on-Chronic Liver Failure
This trial is investigating the combination of Resatorvid (TAK-242) and Granulocyte Colony-Stimulating Factor (G-CSF) in patients with severe alcoholic hepatitis and acute-on-chronic liver failure. The study will test the safety of this combination treatment over a period of up to 10 days.
Main inclusion criteria: Participants must be between 18 and 75 years old and agree to use acceptable contraceptive methods. They must have severe alcoholic hepatitis that does not respond to steroid treatment or cannot take steroids for medical reasons, determined by a Lille score greater than 0.45. Participants must have Grade 1 to 3 acute-on-chronic liver failure with no more than three organ failures, assessed using the CLIF-C OF score and CLIF-C ACLF-CRP score between 35 and 60.
Main exclusion criteria: The trial excludes patients with more than three organ failures (affecting liver, kidneys, brain, blood clotting, breathing, or heart), those with a CLIF-C ACLF-CRP score outside the 35 to 60 range, and patients with Grade 1 ACLF who have a mortality risk greater than 15% at 28 days.
Trial focus: The study evaluates the safety of combining Resatorvid and G-CSF in treating severe liver conditions. Researchers will monitor participants for side effects and assess the treatment’s impact on liver function, inflammation, quality of life, and intensive care days. Regular monitoring will occur throughout the study to track health status and any changes.
Investigational drugs: TAK-242 (Resatorvid) is an anti-inflammatory agent that blocks specific immune system pathways causing inflammation, thereby potentially reducing liver damage. It is administered as a concentrate for solution for infusion. Granulocyte Colony-Stimulating Factor (G-CSF/Neupogen/filgrastim) is a hematopoietic growth factor given via subcutaneous injection that stimulates white blood cell production to help fight infections and support liver recovery. It is administered six times during the study period.
Summary
The four ongoing clinical trials for alcoholic hepatitis represent diverse approaches to treating this serious liver condition. These studies are concentrated primarily in Spain, which hosts two trials, while Austria, France, Germany, and Portugal each host one trial. The research focuses on different therapeutic strategies, including anti-inflammatory treatments, liver-protective agents, and immune system support.
The trials involve various investigational drugs at different stages of development. Alpha-1 Antitrypsin and combination treatments using N-acetylcysteine with methylprednisolone represent approaches using established medications in new contexts, while INT-787 and the combination of Resatorvid with G-CSF represent newer experimental therapies. All studies target patients with severe forms of the disease, as indicated by specific scoring systems such as the Maddrey score, MELD score, and Lille score.
A common thread across these trials is the focus on reducing liver inflammation and preventing disease progression in patients who continue to experience severe symptoms despite standard care. The studies employ rigorous inclusion and exclusion criteria to ensure participant safety and data quality, with particular attention to contraceptive requirements, assessment of disease severity, and exclusion of individuals with multiple organ failures or other complicating conditions.
