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Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Sponsor: Gilead Sciences
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
402
Start Date
2023-09-07
Completion Date
2030-08
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Seladelpar
Administered orally
Placebo
Administered orally
Locations (218)
University of Alabama at Birmingham
Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center - 350 W. Thomas
Phoenix, Arizona, United States
OM Research LLC
Lancaster, California, United States
SCPMG/Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Cedar Sinai Medical Center
Los Angeles, California, United States
California Liver Research Institute
Pasadena, California, United States
Stanford University
Redwood City, California, United States
Kaiser Roseville
Roseville, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
California Pacific Medical Center - Sutter Pacific Medical Foundation
San Francisco, California, United States
Connie Frank Transplant Center at UCSF
San Francisco, California, United States
Kaiser Permanente - South San Francisco Medical Center
South San Francisco, California, United States
Covenant Metabolic Specialists, LLC
Fort Myers, Florida, United States
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, United States
Covenant Metabolic Specialists, LLC
Sarasota, Florida, United States
Florida Research Institute
Tampa, Florida, United States
Piedmont Atlanta Hospital / Piedmont Transplant Institute
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
University of Louisville, Clinical Trials Unit
Louisville, Kentucky, United States
Ochsner Clinic Foundation
Jefferson, Louisiana, United States
University Health System - East Jefferson General Hospital Campus
New Orleans, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Walter Reed National Military
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Medical Center - Columbus
Detroit, Michigan, United States
University of Rochester Medical Center - Strong Memorial Hospital
Rochester, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York, United States
NYU Langone Health
New York, New York, United States
New York-Presbyterian/Weill Cornell Medical Center
New York, New York, United States
Mount Sinai
New York, New York, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
University Hosptials Cleveland Medical Center
Cleveland, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
The Oregon Clinic Gastroenterology East
Portland, Oregon, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
UPMC Center for Liver Diseases
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Gastro One
Cordova, Tennessee, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center, Professional Office Building One
Dallas, Texas, United States
Soma Clinical Trials
Denison, Texas, United States
American Research Corporation
San Antonio, Texas, United States
Pinnacle Clinical Research, PLLC
San Antonio, Texas, United States
MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax
Fairfax, Virginia, United States
Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, United States
VCU Health Clinical Research Services Unit (CRSU)
Richmond, Virginia, United States
Liver Institute Northwest
Seattle, Washington, United States
Medical College of Wisconsin - 8701 Watertown Plan
Milwaukee, Wisconsin, United States
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Consultorios Médicos Dr. Doreski - PPDS
Buenos Aires, Argentina
Buenos Aires Mácula
Buenos Aires, Argentina
Centro de Investigación y Prevención Cardiovascular
Buenos Aires, Argentina
AES - AS - Glenny Corp. S.A. Buenos Aires
Buenos Aires, Argentina
Higea S.A.
Mendoza, Argentina
DIM Clinica Privada
Ramos Mejía, Argentina
CINME S.A. - Centro de Investigaciones Metabólicas
Recoleta, Argentina
Hospital Provincial Del Centenario
Rosario, Argentina
AES - AS - Clinica Mayo de Urgencias
San Miguel de Tucumán, Argentina
Princess Alexandra Hospital
Queensland, Queensland, Australia
Flinders Medical Center
Adelaide, South Australia, Australia
Monash Health, Monash Medical Centre
Clayton, Victoria, Australia
Northern Health
Epping, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Landeskrankenhaus Hall
Hall in Tirol, Austria
Krankenhaus der Barmherzigen Brüder
Vienna, Austria
Medizinische Universität Wien
Vienna, Austria
Klinikum Wels-Grieskirchen GmbH - Standort Wels
Wels, Austria
UZ Antwerpen
Edegem, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven - PPDS
Leuven, Belgium
University of Calgary
Calgary, Canada
University of Alberta
Edmonton, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Canada
Ottawa Hospital
Ottawa, Canada
Diex Recherche - Québec - PPDS
Québec, Canada
Toronto General Hospital
Toronto, Canada
GI Research Institute Foundation
Vancouver, Canada
Centro de Investigación y Prevención Cardiovascular
La Serena, Chile
Pontificia Universidad Católica de Chile
Santiago, Chile
BIOCINETIC Ltda
Santiago, Chile
Clinical Research Chile SpA - PPDS
Valdivia, Chile
Beijing Youan Hospital, Capital Medical University
Beijing, China
Beijing Ditan Hospital, Capital Medical University
Beijing, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
The First Hospital of Jilin University
Changchun, China
West China Hospital of Sichuan University
Chengdu, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, China
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China
Guizhou Provincial People's Hospital
Guiyang, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
The First People's Hospital of Yunnan Province
Kunming, China
The Second Hospital of Nanjing
Nanjing, China