ClinicalTrials.gov record
Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07428538

Public ClinicalTrials.gov record NCT07428538. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 8, 2026, 3:55 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

RE-AHFIRM (RandomizEd Study of Larsucosterol in Alcohol-associated Hepatitis to Confirm saFety and effIcacy of tReatMent)

Study identification

NCT ID
NCT07428538
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bausch Health Americas, Inc.
Industry
Enrollment
350 participants

Conditions and interventions

Conditions

Interventions

  • Larsucosterol Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 28, 2026
Primary completion
Oct 31, 2027
Completion
Jan 31, 2028
Last update posted
May 6, 2026

2026 – 2028

United States locations

U.S. sites
48
U.S. states
25
U.S. cities
38
Facility City State ZIP Site status
University of Alabama at Birmingham (UAB) Hospital Birmingham Alabama 35294 Not yet recruiting
Banner - University Medical Center, Phoenix, Arizona Phoenix Arizona 85006 Not yet recruiting
Mayo Clinic - Phoenix Phoenix Arizona 85054 Not yet recruiting
Southern California GI & Liver Centers - Coronado Coronado California 92118 Not yet recruiting
Cedars Sinai Medical Center Los Angeles California 90048 Not yet recruiting
UCLA Health - Ronald Reagan Medical Center Los Angeles California 90095 Not yet recruiting
Stanford Medicine - Clinical and Translational Research Unit - Redwood City Redwood City California 94063 Not yet recruiting
University of California at Davis Medical Center Sacramento California 95757 Not yet recruiting
Sutter Health San Francisco California 94109 Not yet recruiting
Georgetown University Medical Center Washington D.C. District of Columbia 20007 Not yet recruiting
AdventHealth Transplant Institute Orlando Florida 32804 Not yet recruiting
Tampa General Hospital Tampa Florida 33606 Not yet recruiting
Piedmont Atlanta Hospital - Piedmont Transplant Institute Atlanta Georgia 30309 Not yet recruiting
Rush University Medical Center Chicago Illinois 60612 Not yet recruiting
University of Iowa Hospitals & Clinics Iowa City Iowa 52242 Not yet recruiting
Robley Rex VA Medical Center Louisville Kentucky 40206 Not yet recruiting
Tulane University Health Sciences Center - Tulane Avenue New Orleans Louisiana 70112 Not yet recruiting
Mercy Medical Center - The Institute for Digestive Health and Liver Disease Baltimore Maryland 21202 Recruiting
Johns Hopkins Hospital Baltimore Maryland 21287 Not yet recruiting
Massachusetts General Hospital Boston Massachusetts 02114 Not yet recruiting
Boston University School of Medicine Boston Massachusetts 02118 Not yet recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 Not yet recruiting
UMass Chan Medical School Worcester Massachusetts 01655 Not yet recruiting
University of Michigan Ann Arbor Michigan 48109 Not yet recruiting
Henry Ford Hospital System Detroit Michigan 48202 Not yet recruiting
University of Minnesota Medical Center Minneapolis Minnesota 55414-2924 Not yet recruiting
Rutgers University New Jersey Medical School Newark New Jersey 07103-2425 Not yet recruiting
University of New Mexico (UNM) Hospital Albuquerque New Mexico 87106-4713 Not yet recruiting
Northwell Health Physician Partners Sandra Atlas Bass Center for Liver Diseases Manhasset New York 11030 Not yet recruiting
NYU Langone Health New York New York 10016 Not yet recruiting
Levine Cancer Institute / Atrium Health Charlotte North Carolina 28204 Not yet recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio 44106 Not yet recruiting
The Ohio State University Wexner Medical Center (OSUWMC) Columbus Ohio 43210 Not yet recruiting
Penn State Health, Milton S. Hershey Medical Center Hershey Pennsylvania 17033 Not yet recruiting
VA Medical Center - Philadelphia Philadelphia Pennsylvania 19104-4551 Not yet recruiting
University of Pennsylvania Hospital Philadelphia Pennsylvania 19104 Not yet recruiting
Thomas Jefferson University Hospital Philadelphia Pennsylvania 19107 Not yet recruiting
Temple University Hospital Philadelphia Pennsylvania 19140 Not yet recruiting
Medical University of South Carolina Charleston South Carolina 29425 Recruiting
The Liver Institute at Methodist Dallas Medical Center Dallas Texas 75203 Recruiting
Baylor Scott White Research Institute - Dallas Dallas Texas 75246 Not yet recruiting
Baylor College of Medicine (BCM) - Baylor Clinic Houston Texas 77030 Recruiting
Intermountain Transplant Clinic Murray Utah 84107 Not yet recruiting
University of Utah Health - University of Utah Salt Lake City Utah 84132 Not yet recruiting
University of Virginia Health Charlottesville Virginia 22908 Not yet recruiting
Bon Secours Liver Institute of Richmond Richmond Virginia 23226 Not yet recruiting
Richmond VA Medical Center Richmond Virginia 23249 Recruiting
Marshall Health Huntington West Virginia 25701 Not yet recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07428538, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 6, 2026 · Synced May 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07428538 live on ClinicalTrials.gov.

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