This study, called the ITAALD trial, is for people aged 18 to 70 with severe alcohol-associated hepatitis (sAH), a serious liver condition, and alcohol use disorder (AUD). It aims to see if combining treatments for sAH with specific AUD therapies leads to better outcomes for your liver and alcohol use over 6 months. You would receive either F-652 (an anti-inflammatory drug) or Prednisone (another anti-inflammatory drug) for your sAH. For AUD, you would either receive Acamprosate (a drug to help with alcohol dependency) and counseling, or brief advice and referral to a 12-step program. The study also wants to compare how safe and effective F-652 is compared to Prednisone. The study is currently unclear on its recruitment status and plans to enroll 216 participants.

Study design

This is a multicenter, randomized, double-blinded, placebo-controlled study involving 216 patients. Participants will be assigned to different treatment groups for both their liver condition and alcohol use disorder.

What's involved

Participants will receive either F-652 or Prednisone for 28 days, with F-652 given on days 1 and 7. They will also receive either Acamprosate and counseling, or brief advice and referral to a 12-step program.

Compensation

Not stated in the trial record.

Follow-up

The main outcomes, such as death, liver transplant, and ascites (fluid buildup in the abdomen), will be measured at 6 months after starting treatment. Survival will also be compared at 90 days and one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.