Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
RE-AHFIRM (RandomizEd Study of Larsucosterol in Alcohol-associated Hepatitis to Confirm saFety and effIcacy of tReatMent)
1 other identifier
interventional
350
1 country
48
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2026
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 29, 2026
CompletedFirst Submitted
Initial submission to the registry
February 19, 2026
CompletedFirst Posted
Study publicly available on registry
February 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
May 7, 2026
May 1, 2026
1.8 years
February 19, 2026
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Transplant Free Survival up to Day 90
Up to Day 90
Secondary Outcomes (9)
Overall Survival at Day 90
Day 90
Time to Death up to Day 90
Up to Day 90
Number of Participants with Days Alive and Out of Hospital up to Day 90
Up to Day 90
Time to First Post Discharge All-cause Hospitalization up to Day 90
Up to Day 90
Number of Participants with Intensive Care Unit (ICU) Utilization up to Day 90
Up to Day 90
- +4 more secondary outcomes
Study Arms (2)
Larsucosterol 30 mg
EXPERIMENTALParticipants will receive Larsucosterol 30 milligrams (mg) intravenous infusion on Day 1.
Placebo
PLACEBO COMPARATORParticipants will receive intravenous infusion of placebo matched to Larsucosterol on Day 1.
Interventions
Eligibility Criteria
You may qualify if:
- Able to provide written informed consent (either from participant or participant's legally acceptable representative).
- Onset of jaundice within 8 weeks before hospital admission.
- 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.
- The determination of AH will be based on typical serum chemistry (as determined by local laboratory):
- Serum total bilirubin \>3.0 milligrams per deciliter (mg/dL) (required at randomization)
- ALT \<400 international unit per Liter (IU/L) (required at randomization)
- \<AST \<400 IU/L
- AST \<400 IU/L (required at randomization)
- AST \>50 IU/L (at any time since current hospital admission or leading to this current hospitalization)
- AST/ALT \>1.5 (at any time since current hospital admission or leading to this current hospitalization)
- Maddrey discriminant function (MDF) \>=32, assuming a control prothrombin time of 12 seconds.
- NOTE: If a local laboratory's control time differs from 12 seconds, then the local laboratory's control time should be used. If control time is not stated or is stated as a range, the control time should be calculated by the formula prothrombin time/INR.
- Original Model for End-stage Liver Disease (MELD; not MELD-Na) score: 21-30 (inclusive).
- Male or female participants 18 years of age or older.
- Women of child-bearing potential (defined as females who are not surgically sterile or who are not over the age of 52 and amenorrheic for at least 12 months) must utilize appropriate birth control throughout the 90-day portion of the study. Acceptable methods that may be used are abstinence, birth control pills ("The Pill") or patch, diaphragm, IUD (coil), vaginal ring, condom, surgical sterilization or progestin implant or injection, or sexual activity limited to a sterile (e.g., vasectomized) male partner.
- +3 more criteria
You may not qualify if:
- A participant will be excluded from the study if he or she meets any of the following criteria:
- 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
- Participants experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens.
- 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).
- 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.
- 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.
- Participants with systemic fungal infection of any kind cannot be considered for this trial.
- Serum creatinine \>2.5 mg/dL.
- Participants undergoing continuous veno-venous hemodialysis (CVVH).
- Gastrointestinal bleeding not controlled by local therapy (i.e., band ligation or injection sclerotherapy). Participant who are at high risk of rebleeding or likely in need of TIPS insertion should be excluded.
- TIPS insertion or variceal embolization within the last 4 weeks.
- Known portal vein occlusion.
- A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy.
- Liver biopsy (if carried out) with findings not compatible with AH. NOTE: A post-dose liver biopsy that is not compatible with AH will not be considered a protocol deviation.
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bausch Health Americas, Inc.lead
- Durectcollaborator
Study Sites (48)
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35294, United States
Banner - University Medical Center, Phoenix, Arizona
Phoenix, Arizona, 85006, United States
Mayo Clinic - Phoenix
Phoenix, Arizona, 85054, United States
Southern California GI & Liver Centers - Coronado
Coronado, California, 92118, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
UCLA Health - Ronald Reagan Medical Center
Los Angeles, California, 90095, United States
Stanford Medicine - Clinical and Translational Research Unit - Redwood City
Redwood City, California, 94063, United States
University of California at Davis Medical Center
Sacramento, California, 95757, United States
Sutter Health
San Francisco, California, 94109, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
AdventHealth Transplant Institute
Orlando, Florida, 32804, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Piedmont Atlanta Hospital - Piedmont Transplant Institute
Atlanta, Georgia, 30309, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
Robley Rex VA Medical Center
Louisville, Kentucky, 40206, United States
Tulane University Health Sciences Center - Tulane Avenue
New Orleans, Louisiana, 70112, United States
Mercy Medical Center - The Institute for Digestive Health and Liver Disease
Baltimore, Maryland, 21202, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
UMass Chan Medical School
Worcester, Massachusetts, 01655, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital System
Detroit, Michigan, 48202, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55414-2924, United States
Rutgers University New Jersey Medical School
Newark, New Jersey, 07103-2425, United States
University of New Mexico (UNM) Hospital
Albuquerque, New Mexico, 87106-4713, United States
Northwell Health Physician Partners Sandra Atlas Bass Center for Liver Diseases
Manhasset, New York, 11030, United States
NYU Langone Health
New York, New York, 10016, United States
Levine Cancer Institute / Atrium Health
Charlotte, North Carolina, 28204, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Ohio State University Wexner Medical Center (OSUWMC)
Columbus, Ohio, 43210, United States
Penn State Health, Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
VA Medical Center - Philadelphia
Philadelphia, Pennsylvania, 19104-4551, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
Baylor Scott White Research Institute - Dallas
Dallas, Texas, 75246, United States
Baylor College of Medicine (BCM) - Baylor Clinic
Houston, Texas, 77030, United States
Intermountain Transplant Clinic
Murray, Utah, 84107, United States
University of Utah Health - University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia Health
Charlottesville, Virginia, 22908, United States
Bon Secours Liver Institute of Richmond
Richmond, Virginia, 23226, United States
Richmond VA Medical Center
Richmond, Virginia, 23249, United States
Marshall Health
Huntington, West Virginia, 25701, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jimin Lee, Ph.D
Bausch Health Americas, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2026
First Posted
February 23, 2026
Study Start
January 29, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
February 1, 2028
Last Updated
May 7, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share