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

Recruiting Phase 3 Interventional Study
Hepatitis
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
350 (estimated)
Sponsor
Bausch Health Americas, Inc. · Industry
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About This Trial

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 Locations
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Eligibility Criteria
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 a…
Contacts

Varsha Bhatt

707-230-1712

varsha.bhatt@bauschhealth.com

CONTACT

Alycia Olsen

201-846-8376

Alycia.Olsen@bauschhealth.com

CONTACT