Integrated Therapies for Alcohol Use in Alcohol-associated Liver Disease (ITAALD) Trial
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.
• 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 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 may be performed during current hospital admission to confirm AH and exclude competing etiologies.
• Females of childbearing (reproductive) potential must have a negative serum or urine pregnancy test at screening.