Actively Recruiting
Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial
Led by Samer Gawrieh · Updated on 2026-05-14
216
Participants Needed
6
Research Sites
278 weeks
Total Duration
On this page
Sponsors
S
Samer Gawrieh
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to less than 70 years
- MELD score between 20 and 35 on day of randomization
- Definite or probable diagnosis of severe alcohol-associated hepatitis by NIAAA criteria
- Onset of jaundice with serum total bilirubin >3 mg/dL within the prior 8 weeks
- Ongoing alcohol consumption over 40 gm daily for females or 60 gm daily for males for 6 months or more with less than 8 weeks abstinence before jaundice
- AST over 50 IU/L and AST:ALT ratio greater than 1.5
- ALT and AST values less than 400 IU/L
- Histological evidence of alcohol-associated hepatitis if diagnosis is uncertain
- Negative pregnancy test for females of reproductive potential at screening
You will not qualify if you...
- Listed for liver transplant before screening
- MELD score less than 20 or greater than 35
- Uncontrolled infection despite 48 hours of antibiotics
- Hemodynamic instability requiring intravenous pressors
- Pneumonia confirmed by clinical and radiological exam
- Renal failure with estimated GFR less than 35 mL/min
- Clinically active Clostridium difficile infection
- Other liver diseases such as autoimmune hepatitis or drug-induced liver disease
- History or presence of cancer except non-melanoma skin cancer
- Recent systemic corticosteroid or immunosuppressive therapy over 2 days in past 30 days
- Current use of naltrexone or acamprosate
- Clinically significant pancreatitis
- Active gastrointestinal bleeding causing significant hemoglobin drop or low blood pressure
- Serious medical illnesses like uncontrolled heart failure, COPD, or multi-organ failure
- Uncontrolled mental illness
- Uncontrolled HIV, HBV, or HCV infections with persistent virus
- Recent use of illicit drugs like opiates, cocaine, ketamine, or methamphetamine in last 30 days
- Uncontrolled diabetes with A1c over 9
- Pregnancy or breastfeeding
- Known allergy or intolerance to study medications
- Unwillingness to stop alcohol or undergo AUD treatment
- Unwillingness to abstain from sexual intercourse or use reliable birth control during and 30 days after treatment
- Any condition that may cause noncompliance or affect study data interpretation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
University of Louisville
Louisville, Kentucky, United States, 40292
Actively Recruiting
3
Mayo Clinic
Rochester, Minnesota, United States, 55902
Actively Recruiting
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
5
University of Texas Southwestern Medical School
Dallas, Texas, United States, 15260
Actively Recruiting
6
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Actively Recruiting
Research Team
S
Savannah Yarnelle
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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