Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Gilead Sciences
Study ID
NCT06051617
Phase
PHASE3
Status
Recruiting
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Conditions

  • Primary Biliary Cholangitis

Eligibility Criteria

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

Interventions

  • Seladelpar — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

The goal of this clinical study is to learn more about the study drug, seladelpar, and its effects on clinical outcomes in participants with primary biliary cholangitis (PBC) and compensated cirrhosis. The primary objective of this study is to evaluate the effect of seladelpar compared to placebo on EFS. EFS is defined as the time from start of treatment to the first occurrence of any of the following adjudicated events up to Week 156.

Key Dates

First listed
Sep 25, 2023
Start date
Sep 7, 2023
Status verified
Sep 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2030

Study Design

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

Arms

  • Experimental: Seladelpar
    Participants with Child-Pugh (CP)-A cirrhosis will receive seladelpar 10 mg orally once daily or participants with CP-B cirrhosis will receive seladelpar 5 mg orally once daily, for up to 36 months.
  • Placebo Comparator: Placebo
    Participants with CP-A or CP-B will be randomized to received placebo to match one capsule daily for up to 36 months.
  • Experimental: Open Label Extension Phase
    Participants with CP-A who remained on the study drug at week 156 will receive seladelpar 10 mg daily or participants with CP-B will received seladelpar 5 mg daily for a maximum of 3 years.

Primary Outcome Measure

Event Free Survival (EFS) [ Time Frame: 36 months ]

Central Contacts

Locations (52)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
St. Joseph's Hospital and Medical Center - 350 W. ThomasPhoenixArizona85013-
OM Research LLCLancasterCalifornia93534-
Cedar Sinai Medical CenterLos AngelesCalifornia90048-
SCPMG/Kaiser Permanente Los Angeles Medical CenterLos AngelesCalifornia90027-
California Liver Research InstitutePasadenaCalifornia91105-
Stanford UniversityRedwood CityCalifornia94063-
University of California, Davis Medical CenterSacramentoCalifornia95817-
California Pacific Medical Center - Sutter Pacific Medical FoundationSan FranciscoCalifornia94109-
Connie Frank Transplant Center at UCSFSan FranciscoCalifornia94143-
Kaiser Permanente - South San Francisco Medical CenterSouth San FranciscoCalifornia94080-
Covenant Metabolic Specialists, LLCFort MyersFlorida33912-
Schiff Center for Liver Diseases/University of MiamiMiamiFlorida33136-
Covenant Metabolic Specialists, LLCSarasotaFlorida33912-
Florida Research InstituteTampaFlorida34211-
Piedmont Atlanta Hospital / Piedmont Transplant InstituteAtlantaGeorgia30309-
Northwestern UniversityChicagoIllinois60611-
University of Chicago Medical CenterChicagoIllinois60637-
University Of Iowa Hospitals And ClinicsIowa CityIowa52242-
University of Louisville, Clinical Trials UnitLouisvilleKentucky40202-
Ochsner Clinic FoundationJeffersonLouisiana70121-
University Health System - East Jefferson General Hospital CampusNew OrleansLouisiana70112-
Mercy Medical CenterBaltimoreMaryland21202-
Walter Reed National MilitaryBethesdaMaryland20889-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford Medical Center - ColumbusDetroitMichigan48202-
Mayo ClinicRochesterMinnesota55905-
University of Rochester Medical Center - Strong Memorial HospitalRochesterMinnesota14642-
Northwell Health Center for Liver Disease and TransplantationManhassetNew York11030-
Mount SinaiNew YorkNew York10029-
New York-Presbyterian/Weill Cornell Medical CenterNew YorkNew York10021-
NYU Langone HealthNew YorkNew York10016-
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-
The Cleveland Clinic FoundationClevelandOhio44195-
University Hosptials Cleveland Medical CenterClevelandOhio44106-
The Ohio State University Medical CenterColumbusOhio43210-
Penn State Health Milton S. Hershey Medical CenterHersheyPennsylvania17033-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
University of Pennsylvania Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104-
UPMC Center for Liver DiseasesPittsburghPennsylvania15213-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Gastro OneCordovaTennessee38018-
The Liver Institute at Methodist Dallas Medical CenterDallasTexas75203-
University of Texas Southwestern Medical Center, Professional Office Building OneDallasTexas75390-
Soma Clinical TrialsDenisonTexas75020-
American Research CorporationSan AntonioTexas78215-
Pinnacle Clinical Research, PLLCSan AntonioTexas78229-
MedStar Health Research Institute / MedStar Georgetown Transplant Institute at FairfaxFairfaxVirginia22031-
Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton RoadsNewport NewsVirginia23602-
VCU Health Clinical Research Services Unit (CRSU)RichmondVirginia23298-
Liver Institute NorthwestSeattleWashington98105-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALSt. Joseph's Hospital and Medical Center - 350 W. Thomas· Phoenix, AZOM Research LLC· Lancaster, CACedar Sinai Medical Center· Los Angeles, CASCPMG/Kaiser Permanente Los Angeles Medical Center· Los Angeles, CACalifornia Liver Research Institute· Pasadena, CA

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