RE-AHFIRM (RandomizEd Study of Larsucosterol in Alcohol-associated Hepatitis to Confirm saFety and effIcacy of tReatMent)
Bausch Health Americas, Inc.
Summary
The primary purpose of this study is to evaluate the safety and efficacy of larsucosterol, as determined by transplant-free survival through Day 90 in participants with severe alcohol-associated hepatitis (AH) with pre-treatment Maddrey Discriminant Function (MDF) score greater than or equal to (\>=) 32 and Model for End-stage Liver Disease (MELD) scores 21-30, inclusive.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria- A participant will be eligible for inclusion in this study if he/she meets all the following criteria: 1. Able to provide written informed consent (either from participant or participant's legally acceptable representative). 2. Onset of jaundice within 8 weeks before hospital admission. 3. Average daily consumption of greater than (\>) 40 (females) or \>60 (males) grams alcohol for 6 months or longer, with less than (\<) 8 weeks of abstinence before the onset of jaundice. Judgment regarding daily and long-term alcohol use and onset of jaundice will be made and documented…
Interventions
- DrugLarsucosterol
Larsucosterol intravenous infusion.
- DrugPlacebo
Matching-placebo (sterile water for injection) intravenous infusion.
Locations (48)
- University of Alabama at Birmingham (UAB) HospitalBirmingham, Alabama
- Banner - University Medical Center, Phoenix, ArizonaPhoenix, Arizona
- Mayo Clinic - PhoenixPhoenix, Arizona
- Southern California GI & Liver Centers - CoronadoCoronado, California
- Cedars Sinai Medical CenterLos Angeles, California
- UCLA Health - Ronald Reagan Medical CenterLos Angeles, California