Actively Recruiting
RE-AHFIRM Study of Larsucosterol in Severe Alcohol-associated Hepatitis to Confirm Safety and Efficacy
Led by Bausch Health Americas, Inc. · Updated on 2026-05-07
350
Participants Needed
48
Research Sites
13 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
Researchers are studying larsucosterol to evaluate its safety and effectiveness in adults with severe alcohol-associated hepatitis (AH). This study focuses on participants who have high disease severity scores, specifically a Maddrey Discriminant Function (MDF) score of 32 or more and Model for End-stage Liver Disease (MELD) scores between 21 and 30. The main goal is to measure transplant-free survival up to 90 days after treatment. Participants will be randomly assigned to receive either a single intravenous infusion of larsucosterol at a dose of 30 milligrams or a matching placebo infusion on Day 1. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. This approach helps compare the effects of larsucosterol against placebo in a controlled setting. During the study, participants will be monitored for survival without liver transplant through Day 90, as well as overall survival and hospital-related outcomes up to 180 days. Researchers will also assess changes in liver function scores and bilirubin levels. Participants' health status will be regularly evaluated through clinical assessments and laboratory tests. The study includes ongoing safety monitoring and adherence to alcohol abstinence support programs. Total participation duration spans up to 180 days for follow-up evaluations.
CONDITIONS
Brief 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 (self or legal representative)
- Onset of jaundice within 8 weeks before hospital admission
- Average daily alcohol consumption over 40 grams (females) or 60 grams (males) for 6 months or longer, with less than 8 weeks abstinence before jaundice
- Diagnosis of alcohol-associated hepatitis based on specific serum chemistry criteria including bilirubin >3.0 mg/dL and liver enzyme levels
- Maddrey Discriminant Function score of 32 or higher
- MELD score between 21 and 30 inclusive
- Male or female aged 18 years or older
- Women of child-bearing potential must use effective birth control during the 90-day study period
- Male participants must use contraception and avoid sperm donation during the 90-day study period
- Agree to participate in an alcohol abstinence support program
- Must be dosed within 9 calendar days of hospital admission inclusive of prior hospital time
You will not qualify if you...
- Use of systemic corticosteroids for current alcohol-associated hepatitis before enrollment or history of corticosteroid use exceeding 8 days in last 30 days
- High risk or history of alcohol withdrawal seizures or delirium tremens
- Active infections including bacterial, viral, or fungal infections unless adequately treated
- Serum creatinine greater than 2.5 mg/dL
- Undergoing continuous veno-venous hemodialysis
- Uncontrolled gastrointestinal bleeding or recent TIPS insertion or variceal embolization
- Known portal vein occlusion
- History of refractory ascites with frequent paracenteses
- Liver biopsy not compatible with alcohol-associated hepatitis
- Stage 3 or higher hepatic encephalopathy
- Serious medical conditions expected to cause short-term mortality unrelated to hepatitis
- Other liver diseases such as autoimmune, ischemic, drug-induced, or viral hepatitis B with active infection
- Any active malignancy or recent malignancy except certain skin cancers
- Pregnancy or breastfeeding
- Participation in another interventional trial within 30 days
- History of organ transplantation excluding corneal transplant
- Conditions that could complicate treatment or assessment
- Listed for liver transplant prior to study drug administration
- Concerns about ability to comply with study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive an intravenous infusion of Larsucosterol or placebo on Day 1 to treat alcohol-associated hepatitis.
1 infusion visit (in-person)
Duration - Up to 180 days
Participants are monitored for safety and efficacy outcomes up to 180 days after treatment.
Visits up to Day 7, Day 90, and Day 180 for assessments
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
N
Natalie Pastelak
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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