Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial
Eligible age
18–69 yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
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.
Sponsor: Samer Gawrieh
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ Active listing for liver transplantation before screening
- ✕ MELD score \<20 or \> 35
- ✕ Uncontrolled infection (persistent positive blood or other body fluid cultures despite 48 hours of antibiotic therapy)
- ✕ Progressive hemodynamic compromise requiring intravenous pressors
- ✕ Pneumonia as evidenced by clinical and radiological examination
- ✕ Renal failure defined by estimated GFR \<35 mL/min.
- ✕ Clinically active C. diff infection
- ✕ Evidence of other liver diseases (such as autoimmune hepatitis, primary biliary cholangiopathy, primary sclerosing cholangitis, ischemic, sepsis- or drug-induced liver disease)
Where it's recruiting
Source: ClinicalTrials.gov · NCT07060638 · last updated 2026-06-18