Trials / Recruiting
RecruitingNCT07428538
Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
RE-AHFIRM (RandomizEd Study of Larsucosterol in Alcohol-associated Hepatitis to Confirm saFety and effIcacy of tReatMent)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- Sponsor
- Bausch Health Americas, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Larsucosterol | Larsucosterol intravenous infusion. |
| DRUG | Placebo | Matching-placebo (sterile water for injection) intravenous infusion. |
Timeline
- Start date
- 2026-01-29
- Primary completion
- 2027-06-29
- Completion
- 2027-07-29
- First posted
- 2026-02-23
- Last updated
- 2026-04-03
Locations
48 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07428538. Inclusion in this directory is not an endorsement.