Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial
Eligible age
18–70 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…
- ✓ 1. Age ≥18, \<70
- ✓ 2. MELD 20-35
- ✓ 3. Definitive or probable diagnosis of sAH as defined by the NIAAA criteria4, 5 A. Onset of jaundice (defined as serum total bilirubin \>3 mg/dL) within the prior 8 weeks B. Ongoing average 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; OR If, in the investigator's judgment, alcohol use may have been underreported, available clinical evidence-including collateral history, medical records, prior documentation of alcohol use, alcohol biomarkers such as PEth, or other relevant evidence-indicates that the participant met the protocol-defined alcohol consumption requirement within the 8 weeks before screening.
- ✓ C. AST \> 50 IU/L, D. AST: ALT \> 1.5 E. ALT and AST values \< 400 IU/L F. Liver biopsy findings consistent with AH
- ✓ \*In patients with possible AH or AH with confounding factors such as possible ischemic hepatitis, possible DILI, uncertain history of alcohol use (e.g., patient denies excessive alcohol use), and atypical/abnormal laboratory tests (e.g., AST \< 50 IU/L or \> 400 IU/L, AST/ALT ratio \< 1.5), antinuclear antibody \> 1:160 or SMA \> 1:80, a standard of care liver biopsy will be considered during current hospital admission to confirm AH and exclude competing etiologies.
- ✓ 4. Females of childbearing (reproductive) potential must have a negative serum or urine pregnancy test at screening.
You may not qualify if…
- ✕ 1. Active listing for liver transplantation before screening
- ✕ 2. MELD score \<20 or \> 35
- ✕ 3. Uncontrolled infection (persistent positive blood or other body fluid cultures despite 48 hours of antibiotic therapy)
- ✕ 4. Progressive hemodynamic compromise requiring intravenous pressors
- ✕ 5. Pneumonia as evidenced by clinical and/or radiological examination (will not perform radiology if not indicated by clinical exam)
- ✕ 6. Renal failure defined by estimated GFR (CKD-EPI) \<35 mL/min.
- ✕ 7. Clinically active C. diff infection
- ✕ 8. 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 2026-07-15