Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial
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.
Description
Objectives: 1. To determine whether interventions directed to treat AUD integrated with sAH therapies will improve a composite endpoint of alcohol and liver-related events at 6 months compared to usual care for AUD (primary endpoint). 2. To compare 90-day survival in patients receiving F-652 with those receiving up to 28 days of prednisone using the Day-7 Lille score as a stopping rule (secondary endpoint). 3. To compare one-year overall survival in patients receiving either IL-22 or prednisone with or without acamprosate (secondary endpoint). Trial design and conduct The Investigators will…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Age ≥18, \<70 * MELD 20-35 on day of randomization * Definitive or probable diagnosis as defined by the NIAAA criteria * Onset of jaundice (defined as serum total bilirubin \>3 mg/dL) within the prior 8 weeks * Ongoing consumption of \> 40 gm (for females) and \> 60 gm (for males) alcohol daily for 6 months or more with less than 8 weeks of abstinence before onset of jaundice * AST \> 50 IU/L, * AST: ALT \> 1.5 * ALT and AST values \< 400 IU/L * and/or histological evidence of AH\* \*In patients with possible AH or AH with confounding factors such as possible ischemic…
Interventions
- DrugIL-22
F-652 (IL-22) is a fusion protein of human IL-22 with IgG2 fragment, and has anti-inflammatory effects
- DrugPrednisone
Prednisone is an adrenal glucocorticoid with anti-inflammatory effects
- DrugAcamprosate
Acamprosate is a propane-1 sulfonic acid with anti-ethanol dependency effects
- DrugPrednisone placebo
Matching placebo
- DrugIL-22 (F-652) Placebo
Matching Placebo
- BehavioralMotivational Interviewing (MI)
MI is an evidence-based counseling style to overcome ambivalence to treatment in AUD patients
- Behavioral
Locations (6)
- Indiana UniversityIndianapolis, Indiana
- University of LouisvilleLouisville, Kentucky
- Mayo ClinicRochester, Minnesota
- Cleveland ClinicCleveland, Ohio
- University of Texas Southwestern Medical SchoolDallas, Texas
- Virginia Commonwealth UniversityRichmond, Virginia