Clinical Trial

Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial

Study acronym: ITAALD

Recruiting Phase 2

Summary

This is a multicenter, randomized, double-blinded, placebo-controlled trial focused on the treatment of severe alcohol-associated hepatitis (sAH) and alcohol use disorder (AUD). The primary purpose of the study is to determine whether subjects receiving sAH therapy in addition to AUD treatments will have better alcohol and liver-related outcomes at 6 months compared to sAH therapy plus usual care for AUD. Patients assigned to the AUD treatment will receive Acamprosate and counseling whereas those assigned to AUD standard care will receive brief advice and referral to a 12-step program. The secondary purpose of the study is to determine if F-652 is safe and effective in treating sAH when compared to prednisone. Subjects will receive F-652 on days 1 and 7 or prednisone for 28 days. Outcomes will be measured by overall survival at 90 days.

Protocol Amendment History 6 changes

notable Primary completion pushed: 2029-06 -> 2029-12 2026-06-19

minor Completion pushed: 2029-06 -> 2029-12 2026-06-19

notable Primary completion pushed: 2028-12 -> 2029-06 2026-06-13

notable Primary completion moved earlier: 2029-12 -> 2028-12 2026-06-10

minor Completion moved earlier: 2031-06 -> 2029-06 2026-06-10

minor Completion pushed: 2029-12 -> 2031-06 2026-05-15

Trial Details

NCT Number	NCT07060638
Lead Sponsor	Samer Gawrieh Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions	Alcohol-associated Hepatitis
Enrollment	216 participants
Start Date	2026-01-27
Primary Completion	2029-12 (estimated)
Study Completion	2029-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-15