RecruitingHepatitis

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

Eligible age

18+ yrs

Accepts

All genders

Locations

25 states

Healthy volunteers

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About this study

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.

Sponsor: Bausch Health Americas, Inc.

You may qualify if…

✓ 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 admission.
✓ 3. Average daily consumption of greater than (\>) 40 (females) or \>60 (males) grams alcohol for 6 months or longer, with less than (\<) 8 weeks of abstinence before the onset of jaundice. Judgment regarding daily and long-term alcohol use and onset of jaundice will be made and documented by the site Investigator.
✓ 4. The determination of AH will be based on typical serum chemistry (as determined by local laboratory):
✓ 1. Serum total bilirubin \>3.0 milligrams per deciliter (mg/dL) (required at randomization)
✓ 2. ALT \<400 international unit per Liter (IU/L) (required at randomization)
✓ 3. 50 \<AST \<400 IU/L

You may not qualify if…

✕ A participant will be excluded from the study if he or she meets any of the following criteria:
✕ 1. Participants using systemic corticosteroids for current AH before enrollment or having a history of using systemic corticosteroids for more than 8 days in the last 30 days prior to screening.
✕ NOTE: Inhaled, topical, or local corticosteroid injections are permitted NOTE: A participant who has a confirmed diagnosis of hypoadrenalism and is taking a physiological replacement dose of hydrocortisone (or equivalent) is permitted to take part in the trial
✕ 2. Participants experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens.
✕ 3. Active infection (such as spontaneous bacterial peritonitis \[SBP\], urinary tract infection \[UTI\], cellulitis, pneumonia, bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).
✕ 1. Participants who are febrile with leukocytosis are also excluded until active infection has been excluded to the satisfaction of the PI in consultation with the medical monitor.
✕ 2. Participants with bacterial infections may be enrolled provided they remain in the enrollment window and the infection is adequately treated. For example, participants with bacterial peritonitis may be considered for enrollment once the infection has been treated and follow up paracentesis confirms the absence of SBP.
✕ 3. Participants with systemic fungal infection of any kind cannot be considered for this trial.