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Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial
Sponsor: Samer Gawrieh
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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
216
Start Date
2026-01-27
Completion Date
2029-12
Last Updated
2026-01-30
Healthy Volunteers
No
Conditions
Interventions
IL-22
F-652 (IL-22) is a fusion protein of human IL-22 with IgG2 fragment, and has anti-inflammatory effects
Prednisone
Prednisone is an adrenal glucocorticoid with anti-inflammatory effects
Acamprosate
Acamprosate is a propane-1 sulfonic acid with anti-ethanol dependency effects
Prednisone placebo
Matching placebo
IL-22 (F-652) Placebo
Matching Placebo
Motivational Interviewing (MI)
MI is an evidence-based counseling style to overcome ambivalence to treatment in AUD patients
Motivational Enhancement Therapy (MET)
MET is an MI-based approach that includes 2-4 behavioral treatment sessions based on the Platform Treatment Manual
Usual Care
defined as a brief intervention with advice not to drink alcohol-containing beverages and referral to a 12-step program
Locations (6)
Indiana University
Indianapolis, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Mayo Clinic
Rochester, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Texas Southwestern Medical School
Dallas, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States