Actively Recruiting
Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
Led by Bausch Health Americas, Inc. · Updated on 2026-05-07
350
Participants Needed
48
Research Sites
104 weeks
Total Duration
On this page
Sponsors
B
Bausch Health Americas, Inc.
Lead Sponsor
D
Durect
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent (participant or legally acceptable representative)
- Onset of jaundice within 8 weeks before hospital admission
- Average daily alcohol consumption greater than 40 grams (females) or 60 grams (males) for 6 months or longer with less than 8 weeks of abstinence before jaundice
- Typical serum chemistry indicating alcohol-associated hepatitis: total bilirubin >3.0 mg/dL, ALT <400 IU/L, AST between 50 and 400 IU/L, AST/ALT ratio >1.5
- Maddrey Discriminant Function score >=32
- Model for End-stage Liver Disease (MELD) score between 21 and 30 inclusive
- Male or female participants aged 18 years or older
- Women of child-bearing potential must use appropriate birth control during the 90-day study period
- Male participants must use medically acceptable contraception and avoid sperm donation during the 90-day study period
- Agree to participate in an alcohol abstinence support program
- Participants must be dosed within 9 calendar days of hospital admission inclusive of time spent in other hospitals
You will not qualify if you...
- Use of systemic corticosteroids for current AH before enrollment or more than 8 days in the last 30 days prior to screening
- High risk or history of alcohol withdrawal seizures or delirium tremens
- Active infections including bacterial, viral, fungal, or COVID-19
- Serum creatinine greater than 2.5 mg/dL
- Undergoing continuous veno-venous hemodialysis
- Uncontrolled gastrointestinal bleeding or high risk of rebleeding
- TIPS insertion or variceal embolization within the last 4 weeks
- Known portal vein occlusion
- History of refractory ascites requiring frequent paracenteses
- Liver biopsy findings not compatible with alcohol-associated hepatitis
- Stage 3 or higher hepatic encephalopathy
- Medical conditions posing high short-term mortality risk unrelated to AH, including severe heart, lung, kidney, endocrine, psychiatric conditions, or shock
- Other liver diseases such as autoimmune, ischemic, Wilson disease, drug-induced, hepatitis B or active viral hepatitis
- Active or recent malignancy except curable skin cancer
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial within 30 days
- History of organ transplant (except corneal)
- Underlying diseases that may interfere with treatment or study assessments
- Listed for liver transplant prior to study drug administration
- Concerns about ability or willingness to comply with study schedule
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 48 locations
1
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States, 35294
Not Yet Recruiting
2
Banner - University Medical Center, Phoenix, Arizona
Phoenix, Arizona, United States, 85006
Not Yet Recruiting
3
Mayo Clinic - Phoenix
Phoenix, Arizona, United States, 85054
Not Yet Recruiting
4
Southern California GI & Liver Centers - Coronado
Coronado, California, United States, 92118
Not Yet Recruiting
5
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Not Yet Recruiting
6
UCLA Health - Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
Not Yet Recruiting
7
Stanford Medicine - Clinical and Translational Research Unit - Redwood City
Redwood City, California, United States, 94063
Not Yet Recruiting
8
University of California at Davis Medical Center
Sacramento, California, United States, 95757
Not Yet Recruiting
9
Sutter Health
San Francisco, California, United States, 94109
Not Yet Recruiting
10
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Not Yet Recruiting
11
AdventHealth Transplant Institute
Orlando, Florida, United States, 32804
Not Yet Recruiting
12
Tampa General Hospital
Tampa, Florida, United States, 33606
Not Yet Recruiting
13
Piedmont Atlanta Hospital - Piedmont Transplant Institute
Atlanta, Georgia, United States, 30309
Not Yet Recruiting
14
Rush University Medical Center
Chicago, Illinois, United States, 60612
Not Yet Recruiting
15
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
16
Robley Rex VA Medical Center
Louisville, Kentucky, United States, 40206
Not Yet Recruiting
17
Tulane University Health Sciences Center - Tulane Avenue
New Orleans, Louisiana, United States, 70112
Not Yet Recruiting
18
Mercy Medical Center - The Institute for Digestive Health and Liver Disease
Baltimore, Maryland, United States, 21202
Actively Recruiting
19
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
20
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
21
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
Not Yet Recruiting
22
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
23
UMass Chan Medical School
Worcester, Massachusetts, United States, 01655
Not Yet Recruiting
24
University of Michigan
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
25
Henry Ford Hospital System
Detroit, Michigan, United States, 48202
Not Yet Recruiting
26
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55414-2924
Not Yet Recruiting
27
Rutgers University New Jersey Medical School
Newark, New Jersey, United States, 07103-2425
Not Yet Recruiting
28
University of New Mexico (UNM) Hospital
Albuquerque, New Mexico, United States, 87106-4713
Not Yet Recruiting
29
Northwell Health Physician Partners Sandra Atlas Bass Center for Liver Diseases
Manhasset, New York, United States, 11030
Not Yet Recruiting
30
NYU Langone Health
New York, New York, United States, 10016
Not Yet Recruiting
31
Levine Cancer Institute / Atrium Health
Charlotte, North Carolina, United States, 28204
Not Yet Recruiting
32
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
33
The Ohio State University Wexner Medical Center (OSUWMC)
Columbus, Ohio, United States, 43210
Not Yet Recruiting
34
Penn State Health, Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Not Yet Recruiting
35
VA Medical Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4551
Not Yet Recruiting
36
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
37
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Not Yet Recruiting
38
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Not Yet Recruiting
39
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
40
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Actively Recruiting
41
Baylor Scott White Research Institute - Dallas
Dallas, Texas, United States, 75246
Not Yet Recruiting
42
Baylor College of Medicine (BCM) - Baylor Clinic
Houston, Texas, United States, 77030
Actively Recruiting
43
Intermountain Transplant Clinic
Murray, Utah, United States, 84107
Not Yet Recruiting
44
University of Utah Health - University of Utah
Salt Lake City, Utah, United States, 84132
Not Yet Recruiting
45
University of Virginia Health
Charlottesville, Virginia, United States, 22908
Not Yet Recruiting
46
Bon Secours Liver Institute of Richmond
Richmond, Virginia, United States, 23226
Not Yet Recruiting
47
Richmond VA Medical Center
Richmond, Virginia, United States, 23249
Actively Recruiting
48
Marshall Health
Huntington, West Virginia, United States, 25701
Not Yet Recruiting
Research Team
V
Varsha Bhatt
CONTACT
N
Natalie Pastelak
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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