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NCT07428538
Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
Conditions: Hepatitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 350
Sponsor: Bausch Health Americas, Inc.
Location: University of Alabama at Birmingham (UAB) Hospital Birmingham Alabama
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.
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 admission.
3. Average daily consumption of greater than (\>) 40 (females) or \>60 (males) grams alcohol for 6 months or longer, with less than (\3.0 milligrams per deciliter (mg/dL) (required at randomization)
2. ALT \=500 msec, or high-grade AV block)
3. Ventilator-dependent respiratory failure, or Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Stage III or IV chronic obstructive pulmonary disease \[COPD\])
4. End-stage renal disease requiring chronic, ongoing dialysis
5. Severe uncontrolled endocrine or metabolic disorders
6. Severe psychiatric illness likely to interfere with study participation
7. Hypotension/shock as defined by the North American Consortium for the study of End-stage Liver Disease (NACSELD) criteria (i.e., Mean Arterial Pressure \[MAP\] \4 weeks is anticipated.
7. Acute hepatitis A (if test performed per SOC)
8. Acute HCV or chronic hepatitis C with a history of decompensated cirrhosis. NOTE: participants with stable chronic HCV or successfully treated HCV are not excluded
9. Acute hepatitis E (if test performed per SOC)
10. Acute cytomegalovirus (CMV) viral hepatitis (if test performed per SOC)
14. Any known active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas).
15. Existing or intended pregnancy or breast feeding.
16. Participation in another interventional clinical trial within 30 days of Screening.
17. History of organ transplantation other than corneal transplant.
18. Underlying disease that, in the opinion of the site Investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug.
19. Participant listed for liver transplant (LT) prior to study drug administration.
20. Concern of participant's willingness and ability to be compliant with the schedule of protocol assessments, per the Investigator's judgement.
Source: ClinicalTrials.gov (NCT07428538). StuddyBuddy aggregates publicly available trial information.