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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bausch Health Americas, Inc.
Study ID
NCT07428538
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Hepatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Larsucosterol — DRUG
    Larsucosterol intravenous infusion.
  • Placebo — DRUG
    Matching-placebo (sterile water for injection) intravenous infusion.

Study Details

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.

Key Dates

Start date
Jan 29, 2026
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Larsucosterol 30 mg
    Participants will receive Larsucosterol 30 milligrams (mg) intravenous infusion on Day 1.
  • Placebo Comparator: Placebo
    Participants will receive intravenous infusion of placebo matched to Larsucosterol on Day 1.

Primary Outcome Measure

Transplant Free Survival up to Day 90 [ Time Frame: Up to Day 90 ]

Central Contacts

Locations (48)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham (UAB) HospitalBirminghamAlabama35294-
Banner - University Medical Center, Phoenix, ArizonaPhoenixArizona85006-
Mayo Clinic - PhoenixPhoenixArizona85054-
Southern California GI & Liver Centers - CoronadoCoronadoCalifornia92118-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
UCLA Health - Ronald Reagan Medical CenterLos AngelesCalifornia90095-
Stanford Medicine - Clinical and Translational Research Unit - Redwood CityRedwood CityCalifornia94063-
University of California at Davis Medical CenterSacramentoCalifornia95757-
Sutter HealthSan FranciscoCalifornia94109-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
AdventHealth Transplant InstituteOrlandoFlorida32804-
Tampa General HospitalTampaFlorida33606-
Piedmont Atlanta Hospital - Piedmont Transplant InstituteAtlantaGeorgia30309-
Rush University Medical CenterChicagoIllinois60612-
University of Iowa Hospitals & ClinicsIowa CityIowa52242-
Robley Rex VA Medical CenterLouisvilleKentucky40206-
Tulane University Health Sciences Center - Tulane AvenueNew OrleansLouisiana70112-
Johns Hopkins HospitalBaltimoreMaryland21287-
Mercy Medical Center - The Institute for Digestive Health and Liver DiseaseBaltimoreMaryland21202-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Boston University School of MedicineBostonMassachusetts02118-
Massachusetts General HospitalBostonMassachusetts02114-
UMass Chan Medical SchoolWorcesterMassachusetts01655-
University of MichiganAnn ArborMichigan48109-
Henry Ford Hospital SystemDetroitMichigan48202-
University of Minnesota Medical CenterMinneapolisMinnesota55414-2924-
Rutgers University New Jersey Medical SchoolNewarkNew Jersey07103-2425-
University of New Mexico (UNM) HospitalAlbuquerqueNew Mexico87106-4713-
Northwell Health Physician Partners Sandra Atlas Bass Center for Liver DiseasesManhassetNew York11030-
NYU Langone HealthNew YorkNew York10016-
Levine Cancer Institute / Atrium HealthCharlotteNorth Carolina28204-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
The Ohio State University Wexner Medical Center (OSUWMC)ColumbusOhio43210-
Penn State Health, Milton S. Hershey Medical CenterHersheyPennsylvania17033-
Temple University HospitalPhiladelphiaPennsylvania19140-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
University of Pennsylvania HospitalPhiladelphiaPennsylvania19104-
VA Medical Center - PhiladelphiaPhiladelphiaPennsylvania19104-4551-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Baylor Scott White Research Institute - DallasDallasTexas75246-
The Liver Institute at Methodist Dallas Medical CenterDallasTexas75203-
Baylor College of Medicine (BCM) - Baylor ClinicHoustonTexas77030-
Intermountain Transplant ClinicMurrayUtah84107-
University of Utah Health - University of UtahSalt Lake CityUtah84132-
University of Virginia HealthCharlottesvilleVirginia22908-
Bon Secours Liver Institute of RichmondRichmondVirginia23226-
Richmond VA Medical CenterRichmondVirginia23249-
Marshall HealthHuntingtonWest Virginia25701-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham (UAB) Hospital· Birmingham, ALBanner - University Medical Center, Phoenix, Arizona· Phoenix, AZMayo Clinic - Phoenix· Phoenix, AZSouthern California GI & Liver Centers - Coronado· Coronado, CACedars Sinai Medical Center· Los Angeles, CAUCLA Health - Ronald Reagan Medical Center· Los Angeles, CA