Tests seladelpar in people with primary biliary cholangitis and compensated cirrhosis
Tests seladelpar against placebo in adults with liver disease and cirrhosis.
Plain-language title generated from the registry record
Registry title: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Key facts
- Where
- Atlanta, Baltimore, Bethesda, Birmingham, Boston, Charleston, Chicago, Cleveland, Columbus, Cordova, Dallas, Denison, Detroit, Fairfax, Fort Myers, Hershey, Iowa City, Jefferson, Lancaster, Los Angeles, Louisville, Manhasset, Miami, Milwaukee, New Orleans, New York, Newport News, Pasadena, Philadelphia, Phoenix, Pittsburgh, Portland, Redwood City, Richmond, Rochester, Roseville, Sacramento, San Antonio, San Francisco, Sarasota, Seattle, South San Francisco, Tampa, and Winston-Salem, United StatesSee the 55 sites
- Phase
- Phase 3
Where in United States
- Piedmont Atlanta Hospital/Piedmont Transplant InstituteAtlanta, United StatesTaking people
- Mercy Medical CenterBaltimore, United StatesTaking people
- Walter Reed National MilitaryBethesda, United StatesTaking people
- University of Alabama at BirminghamBirmingham, United StatesTaking people
- Beth Israel Deaconess Medical CenterBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesTaking people
- Northwestern UniversityChicago, United StatesTaking people
- University of Chicago Medical CenterChicago, United StatesTaking people
- The Cleveland Clinic FoundationCleveland, United StatesTaking people
- University Hosptials Cleveland Medical CenterCleveland, United StatesTaking people
- The Ohio State University Medical CenterColumbus, United StatesTaking people
- Gastro OneCordova, United StatesTaking people
- The Liver Institute at Methodist Dallas Medical CenterDallas, United StatesTaking people
- University of Texas Southwestern Medical Center, Professional Office Building OneDallas, United StatesTaking people
- Soma Clinical TrialsDenison, United StatesTaking people
- Henry Ford Medical Center - ColumbusDetroit, United StatesTaking people
- MedStar Health Research Institute / MedStar Georgetown Transplant Institute at FairfaxFairfax, United StatesTaking people
- Covenant Metabolic Specialists, LLCFort Myers, United StatesTaking people
- Penn State Health Milton S. Hershey Medical CenterHershey, United StatesTaking people
- University of Iowa Hospitals and ClinicsIowa City, United StatesTaking people
- Ochsner Clinic FoundationJefferson, United StatesTaking people
- Om Research LLCLancaster, United StatesTaking people
- Cedar Sinai Medical CenterLos Angeles, United StatesTaking people
- SCPMG/Kaiser Permanente Los Angeles Medical CenterLos Angeles, United StatesTaking people
- University of Louisville, Clinical Trials UnitLouisville, United StatesTaking people
- Northwell Health Center for Liver Disease and TransplantationManhasset, United StatesTaking people
- Schiff Center for Liver Diseases/University of MiamiMiami, United StatesTaking people
- Medical College of Wisconsin - 8701 Watertown PlanMilwaukee, United StatesTaking people
- University Health System - East Jefferson General Hospital CampusNew Orleans, United StatesTaking people
- Mount SinaiNew York, United StatesTaking people
- New York - Presbyterian - Weill Cornell Medical CenterNew York, United StatesTaking people
- NYU Langone HealthNew York, United StatesTaking people
- Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton RoadsNewport News, United StatesTaking people
- California Liver Research InstitutePasadena, United StatesTaking people
- Thomas Jefferson UniversityPhiladelphia, United StatesTaking people
- University of Pennsylvania - Perelman Center for Advanced MedicinePhiladelphia, United StatesTaking people
- St. Joseph's Hospital and Medical Center - 350 W. ThomasPhoenix, United StatesTaking people
- UPMC - Center for Liver DiseasesPittsburgh, United StatesTaking people
- The Oregon Clinic Gastroenterology-EastPortland, United StatesTaking people
- Stanford UniversityRedwood City, United StatesTaking people
- VCU Health Clinical Research Services Unit (CRSU)Richmond, United StatesTaking people
- Mayo ClinicRochester, United StatesTaking people
- University of Rochester Medical Center - Strong Memorial HospitalRochester, United StatesTaking people
- Kaiser RosevilleRoseville, United StatesTaking people
- University of California, Davis Medical CenterSacramento, United StatesTaking people
- American Research CorporationSan Antonio, United StatesTaking people
- Pinnacle Clinical Research, PLLCSan Antonio, United StatesTaking people
- California Pacific Medical Center - Sutter Pacific Medical FoundationSan Francisco, United StatesTaking people
- Connie Frank Transplant Center at UCSFSan Francisco, United StatesTaking people
- Covenant Metabolic Specialists, LLCSarasota, United StatesTaking people
- Liver Institute NorthwestSeattle, United StatesTaking people
- Kaiser Permanente - South San Francisco Medical CenterSouth San Francisco, United StatesTaking people
- Florida Research InstituteTampa, United StatesTaking people
- Wake Forest Baptist Medical CenterWinston-Salem, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gilead Sciences
- Trial code
- NCT06051617EU 2024-516525-31-01
- Record updated
- 2 November 2026
- Original description
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.Read full original descriptionShow less
AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
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.
Inclusion: Individuals must meet the following criteria to be eligible for study participation:; Must be at least 18 years old; Must have a confirmed prior diagnosis of primary biliary cholangitis (PBC); Evidence of cirrhosis; CP Score A or B; Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose; Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA).
Exclusion: Prior exposure to seladelpar; Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI; History or presence of other concomitant liver diseases; A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study; History of liver transplantation or actively listed for cadaveric or planned living donor transplant; Laboratory parameters at Screening:; Alkaline phosphatase (ALP) < 1.5× Upper limit of normal (ULN) or ≥ 10×ULN; Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN; Total bilirubin (TB) ≤ 0.6 × ULN or ≥ 5 × ULN; Platelet count ≤50×10\^3/µL; Albumin ≤2.8 g/dL; Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m\^2; MELD score >12. For individuals on anticoagulation medication, baseline International normalized ratio (INR) determination for MELD score calculation should take anticoagulant use into account, in consultation with the Medical Monitor; Serum alpha-fetoprotein (AFP) >20 ng/mL; INR >1.7; Individuals must not meet any of the following criteria to be eligible for study participation:; Decompensated cirrhosis; Hospitalization for liver-related complication within 12 weeks of Screening; CP-C cirrhosis.