ClinicalTrials.gov record
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.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07428538
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 350 participants
Conditions and interventions
Conditions
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
- Aug 23, 2026
2026 – 2028
United States locations
- U.S. sites
- 86
- U.S. states
- 34
- U.S. cities
- 65
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) Hospital | Birmingham | Alabama | 35294 | Recruiting |
| University of South Alabama | Mobile | Alabama | 36602 | Not yet recruiting |
| Banner - University Medical Center, Phoenix, Arizona | Phoenix | Arizona | 85006 | Recruiting |
| Mayo Clinic - Phoenix | Phoenix | Arizona | 85054 | Not yet recruiting |
| Southern California GI & Liver Centers - Coronado | Coronado | California | 92118 | Withdrawn |
| Scripps | La Jolla | California | 92037 | Not yet recruiting |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | 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 | Recruiting |
| Sutter Health | San Francisco | California | 94109 | Recruiting |
| Yale School of Medicine | New Haven | Connecticut | 06510 | Not yet recruiting |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | Not yet recruiting |
| Mayo Clinic | Jacksonville | Florida | 32202 | Not yet recruiting |
| Reliant Medical Research | Miami | Florida | 33131 | Not yet recruiting |
| University of Miami | Miami | Florida | 33131 | Not yet recruiting |
| AdventHealth Transplant Institute | Orlando | Florida | 32804 | Not yet recruiting |
| AdventHealth Medical Campus | Tampa | Florida | 33602 | Not yet recruiting |
| Tampa General Hospital | Tampa | Florida | 33606 | Not yet recruiting |
| Piedmont Atlanta Hospital - Piedmont Transplant Institute | Atlanta | Georgia | 30309 | Recruiting |
| Augusta University | Augusta | Georgia | 30901 | Not yet recruiting |
| Northwestern University - Feinberg School of Medicine | Chicago | Illinois | 60601 | Not yet recruiting |
| Rush University Medical Center | Chicago | Illinois | 60612 | Not yet recruiting |
| Loyola University Medical Center (LUMC) | Maywood | Illinois | 60153 | Not yet recruiting |
| Indiana Institute for Medical Research (Indiana VA) | Indianapolis | Indiana | 46204 | Not yet recruiting |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | Recruiting |
| University of Kentucky -Chandler Medical Center | Lexington | Kentucky | 40507 | 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 | Recruiting |
| Maine Medical Center - Bramhall Campus | Portland | Maine | 04102-3134 | 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 |
| Tufts Medical Center | Boston | Massachusetts | 02108 | 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 | Recruiting |
| Henry Ford Hospital System | Detroit | Michigan | 48202 | Not yet recruiting |
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55414-2924 | Not yet recruiting |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64106 | Not yet recruiting |
| University of Nevada Las Vegas | Las Vegas | Nevada | 89101 | Not yet recruiting |
| Virtua Medical Group (VMG) - Virtua Center for Liver Disease - Toms River | Camden | New Jersey | 08102 | 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 | Recruiting |
| Northwell Health Physician Partners Sandra Atlas Bass Center for Liver Diseases | Manhasset | New York | 11030 | Recruiting |
| Columbia University Medical Center (CUMC) - Presbyterian Hospital and Vanderbilt Clinic | New York | New York | 10007 | Not yet recruiting |
| NYU Langone Health | New York | New York | 10016 | Not yet recruiting |
| University of Rochester Medical Center | Rochester | New York | 14604 | Not yet recruiting |
| Montefiore Medical Center | The Bronx | New York | 10467 | Not yet recruiting |
| University of North Carolina (UNC Hospitals) | Chapel Hill | North Carolina | 27514 | Not yet recruiting |
| Levine Cancer Institute / Atrium Health | Charlotte | North Carolina | 28204 | Not yet recruiting |
| Duke University Hospital | Durham | North Carolina | 27710 | Not yet recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Not yet recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44114 | Not yet recruiting |
| The Ohio State University Wexner Medical Center (OSUWMC) | Columbus | Ohio | 43210 | Recruiting |
| Oregon Health & Science University | Portland | Oregon | 97204 | Not yet recruiting |
| Penn State Health, Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | Recruiting |
| VA Medical Center - Philadelphia | Philadelphia | Pennsylvania | 19104-4551 | Not yet recruiting |
| University of Pennsylvania Hospital | Philadelphia | Pennsylvania | 19104 | Not yet recruiting |
| Einstein Medical Center Philadelphia | Philadelphia | Pennsylvania | 19107 | Not yet recruiting |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | Not yet recruiting |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | Not yet recruiting |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15222 | Not yet recruiting |
| Ralph H. Johnson Department of Veterans Affairs Medical Center | Charleston | South Carolina | 29401 | Not yet recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Recruiting |
| Galen Medical Group - Galen Hepatology | Chattanooga | Tennessee | 37402 | Not yet recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37219 | Not yet 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 |
| North Texas Gastroenterology | Denton | Texas | 76201 | Not yet recruiting |
| Baylor Scott & White All Saints Medical Center - Fort Worth | Fort Worth | Texas | 76104 | Not yet recruiting |
| Clinical Trial Network - Houston | Houston | Texas | 77002 | Not yet recruiting |
| Baylor College of Medicine (BCM) - Baylor Clinic | Houston | Texas | 77030 | Recruiting |
| Methodist Healthcare - Methodist Hospital Specialty and Transplant | San Antonio | Texas | 78205 | Not yet recruiting |
| Baylor Scott White Research Institute - Temple | Temple | Texas | 76501 | Not yet recruiting |
| Intermountain Transplant Clinic | Murray | Utah | 84107 | Recruiting |
| University of Utah Health - University of Utah | Salt Lake City | Utah | 84132 | Not yet recruiting |
| University of Virginia Health | Charlottesville | Virginia | 22908 | Recruiting |
| Bon Secours Liver Institute of Richmond | Richmond | Virginia | 23226 | Recruiting |
| Richmond VA Medical Center | Richmond | Virginia | 23249 | Recruiting |
| Swedish Medical Center | Seattle | Washington | 98101 | Not yet recruiting |
| UW Medicine-Harborview Medical Center | Seattle | Washington | 98101 | Not yet recruiting |
| Virginia Mason Medical Center (VMMC) - Seattle | Seattle | Washington | 98101 | Not yet recruiting |
| Marshall Health | Huntington | West Virginia | 25701 | Not yet recruiting |
| University of Wisconsin-Madison | Madison | Wisconsin | 53703 | 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 Aug 23, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07428538 live on ClinicalTrials.gov.