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NCT07428538 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
A Phase 3 study of Hepatitis, sponsored by Bausch Health Americas.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
- 1
- Study location
NCT07428538: Recruiting Phase 3 study of Hepatitis, sponsored by Bausch Health Americas.
NCT07428538 is a Phase 3 study of Hepatitis that is actively recruiting participants, run by Bausch Health Americas. The registered enrollment target is 350 participants, above the 200-participant average among 5 other Hepatitis trials with a reported enrollment target (75% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07428538, a Phase 3 study of Hepatitis, is actively recruiting participants, sponsored by Bausch Health Americas.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG Larsucosterol
Study Locations (1)
Texas
- The Liver Institute at Methodist Dallas Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2026-01-29 |
| Est. Completion | 2028-07-29 |
| Phase | Phase 3 |
What NCT07428538 shows while recruiting
NCT07428538 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, above the 200-participant average among 5 other Hepatitis trials with a reported enrollment target (75% higher).
The record links to 1 condition, with Hepatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07428538 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT07428538 about?
NCT07428538 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)". 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 (\>=...
What is the current status of trial NCT07428538?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2026-01-29. Estimated completion is 2028-07-29.
What conditions does trial NCT07428538 study?
This clinical trial studies the following conditions: Hepatitis.
What interventions are being tested in trial NCT07428538?
The interventions under investigation include: Placebo (DRUG), Larsucosterol (DRUG).
Who is sponsoring clinical trial NCT07428538?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07428538 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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