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