Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Hepatitis
In brief
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.
Key facts
- Study ID
- NCT07428538
- Run by
- Bausch Health Americas, Inc.
- People needed
- 350
- Starts
- 2026-01-29
- Expected to finish
- 2028-02-01
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Bon Secours Liver Institute of Richmond — Richmond, Virginia, United States (enrolling)
- University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama, United States (enrolling)
- Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
- Banner - University Medical Center, Phoenix, Arizona — Phoenix, Arizona, United States (enrolling)
- Piedmont Atlanta Hospital - Piedmont Transplant Institute — Atlanta, Georgia, United States (enrolling)
- University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States (enrolling)
- Tulane University Health Sciences Center - Tulane Avenue — New Orleans, Louisiana, United States (enrolling)
- The Ohio State University Wexner Medical Center (OSUWMC) — Columbus, Ohio, United States (enrolling)
- Baylor College of Medicine (BCM) - Baylor Clinic — Houston, Texas, United States (enrolling)
- Richmond VA Medical Center — Richmond, Virginia, United States (enrolling)
- University of Virginia Health — Charlottesville, Virginia, United States (enrolling)
- The Liver Institute at Methodist Dallas Medical Center — Dallas, Texas, United States (enrolling)
- Northwell Health Physician Partners Sandra Atlas Bass Center for Liver Diseases — Manhasset, New York, United States (enrolling)
- Mercy Medical Center - The Institute for Digestive Health and Liver Disease — Baltimore, Maryland, United States (enrolling)
- Reliant Medical Research — Miami, Florida, United States
- Mayo Clinic — Jacksonville, Florida, United States
- Cedars Sinai Medical Center — Los Angeles, California, United States
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- Loyola University Medical Center (LUMC) — Maywood, Illinois, United States
- Yale School of Medicine — New Haven, Connecticut, United States
- Scripps — La Jolla, California, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Northwestern University - Feinberg School of Medicine — Chicago, Illinois, United States
- Indiana Institute for Medical Research (Indiana VA) — Indianapolis, Indiana, United States
- Sutter Health — San Francisco, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.