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Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 86 → 92 locations Eligibility criteria expanded, about 34 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 34 words
  2. Study sites: 84 to 86v5
  3. Trial sites expanded: 48 → 84 locationsv4
  4. Primary completion pushed from Jun 29, 2027 to Nov 2027 Completion pushed from Jul 29, 2027 to Feb 2028 · Site details revised at 3 of 48 sitesv3 Show 2 more changesShow less
    • Completion pushed from Jul 29, 2027 to Feb 2028
    • Site details revised at 3 of 48 sites
  5. Primary completion moved earlier from Jun 29, 2028 to Jun 29, 2027 Trial sites expanded: 1 → 48 locations · Completion moved earlier from Jul 29, 2028 to Jul 29, 2027v2 Show 2 more changesShow less
    • Trial sites expanded: 1 → 48 locations
    • Completion moved earlier from Jul 29, 2028 to Jul 29, 2027
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07428538
Lead Sponsor Bausch Health Americas, Inc.
Collaborators: Durect
Conditions Hepatitis
Enrollment 350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov