Condition: Alcohol-associated Hepatitis · Sponsor: Samer Gawrieh
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.
This description comes directly from the study's public registry record.
Savannah Yarnelle · 3172786424 · samussel@iu.edu
Always discuss trial participation with your own doctor first.
| Indiana University | Indianapolis, Indiana, United States | Recruiting |
| University of Louisville | Louisville, Kentucky, United States | Recruiting |
| Mayo Clinic | Rochester, Minnesota, United States | Recruiting |
| Cleveland Clinic | Cleveland, Ohio, United States | Recruiting |
| University of Texas Southwestern Medical School | Dallas, Texas, United States | Recruiting |
| Virginia Commonwealth University | Richmond, Virginia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07060638