Not recruiting

Study on the Effects of INT-787 for Patients with Severe Alcohol-Associated Hepatitis

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Severe Alcohol-Associated Hepatitis, a serious liver condition caused by excessive alcohol consumption. The study is testing a new treatment called INT-787, which is taken in the form of a capsule. The purpose of the study is to evaluate how effective INT-787 is in managing the progression of this liver disease.

Participants in the study will be randomly assigned to receive either the INT-787 treatment or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The treatment period will last for up to 28 days, during which the safety and tolerability of INT-787 will also be assessed.

The study aims to gather information on how INT-787 affects the liver condition over time, with a particular focus on its safety and how well it is tolerated by participants. The results will help determine if INT-787 could be a potential treatment option for people suffering from Severe Alcohol-Associated Hepatitis.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's purpose and procedures. Written consent is required to participate.
Eligibility is confirmed based on specific criteria, including age, medical condition, and alcohol use history.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the patient's health status. This includes checking liver function and other relevant health indicators.
Step 3
Medication administration
The patient will receive either the investigational medication INT-787 or a placebo. Both are administered in capsule form for oral use.
The dosage and frequency of administration will be determined by the study protocol.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the patient's response to the treatment. This includes evaluating the Lille score on Day 7 to measure efficacy.
Additional follow-up visits are scheduled to ensure the patient's safety and to gather data on the treatment's effects.
Step 5
Completion of the study
Upon completion of the study, a final assessment is conducted to evaluate the overall impact of the treatment.
The patient will be informed about the study's findings and any further steps if necessary.

Who can join the trial?

17 criteria

Participants must be males or females aged between 18 and 65 years old.
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Participants must have a clinical diagnosis of severe alcohol-associated hepatitis (sAH), which includes:
- A history of drinking too much alcohol for at least 6 months, with less than 60 days of not drinking before the start of yellowing of the skin (jaundice).
- A blood test showing serum total bilirubin greater than 3.0 mg/dL. Bilirubin is a substance made by the liver.
- A blood test showing AST (a liver enzyme) of 50 U/L or higher.
- An AST/ALT ratio of 1.5 or more. This is a comparison of two liver enzymes.
- The start of jaundice within the last 8 weeks.
- A Modified Maddrey’s Discriminant Function (mDF) score between 32 and 70. This score helps assess the severity of liver disease.
- A MELD score between 18 and 25. This score predicts the severity of liver disease.
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  Female participants must be postmenopausal, surgically sterile, or if they can still have children, they must use at least one highly effective method of birth control from the start of the study and for 90 days after the last dose of the study drug. Options include:
  - Surgical sterilization (like having tubes tied).
  - Using an intrauterine device (IUD) or system.
  - Using hormonal birth control that stops ovulation, such as pills, vaginal rings, or patches.
  - Using progesterone-only hormonal birth control, such as pills, injections, or implants.
  - Choosing not to have sexual activity that could lead to pregnancy.
  - Male participants who are sexually active with female partners who can have children must agree to use a condom with spermicide and one other approved method of effective birth control from the start of the study and for at least 90 days after the last dose of the study drug.
  - Male participants must not donate sperm from the start of the study and for at least 90 days after the last dose of the study drug.
  - Participants must provide written informed consent, which means they agree to take part in the study and follow the study rules. If a participant has hepatic encephalopathy (a condition that affects brain function due to liver disease) and cannot make decisions, consent will be obtained according to hospital procedures, possibly from a legally authorized representative.
  - Participants must agree to join an alcohol use disorder program during the study, as recommended by local addiction specialists, including after leaving the hospital.

Who cannot join the trial?

7 criteria

Patients who have other serious liver diseases besides Severe Alcohol-Associated Hepatitis cannot participate. This means if you have liver problems not caused by alcohol, you may not be eligible.
Patients who are pregnant or breastfeeding are not allowed to join the study. This is to ensure the safety of both the mother and the baby.
Patients who have a history of severe allergic reactions to medications or treatments may be excluded. This is to prevent any potential health risks during the trial.
Patients who are currently participating in another clinical trial are not eligible. This is to avoid any interference with the results of the study.
Patients who have a history of certain mental health conditions that could affect their ability to follow the study procedures may be excluded. This is to ensure that participants can safely and effectively complete the trial.
Patients who have a history of drug abuse, other than alcohol, may not be eligible. This is to ensure that the study results are not affected by other substances.
Patients who have certain medical conditions that could interfere with the study or pose a risk to their health may be excluded. This is to ensure the safety of all participants.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centre Hospitalier Regional D'Angers
Angers, France
Verified
Centre Hospitalier Universitaire De Lille
Lille, France
Verified
Hopital Beaujon
Clichy, France

Trial locations

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Investigated drugs

INT-787 is being studied to see if it can help people with severe alcohol-associated hepatitis. This condition affects the liver due to heavy alcohol use. The trial aims to find out if INT-787 can slow down or stop the disease from getting worse. Researchers are also looking at how safe and tolerable the medication is for patients, as well as how the body processes it.

Int-787

What is already known about the treatment

INT-787 – This medication is administered orally and is currently being studied in clinical trials for its potential use in treating severe alcohol-associated hepatitis. It is in the experimental phase, specifically a Phase 2a trial, which means it is being tested for safety, tolerability, and efficacy. The main therapeutic indication for INT-787 is to slow or halt the progression of severe alcohol-associated hepatitis. At the molecular level, it is believed to work by modulating specific pathways involved in liver inflammation and damage. INT-787 falls under the pharmacological classification of investigational drugs, as it is still undergoing research to determine its effectiveness and safety in medical use.

Investigated diseases

Severe Alcohol-Associated Hepatitis – This disease is a serious liver condition that occurs due to excessive alcohol consumption. It is characterized by inflammation and damage to liver cells, leading to impaired liver function. Patients may experience symptoms such as jaundice, abdominal pain, and swelling due to fluid accumulation. As the disease progresses, it can lead to liver failure if the liver is unable to repair itself. The condition is often accompanied by systemic inflammation and can affect other organs. It is crucial to address the underlying alcohol use to prevent further liver damage.