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Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Sponsor: Gilead Sciences
Summary
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
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
318
Start Date
2023-09-07
Completion Date
2030-08
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
Seladelpar
* Seladelpar 10 mg one capsule daily for up to 36 months in participants with CP-A cirrhosis or * Seladelpar 5 mg one capsule daily for up to 36 months in participants with CP-B cirrhosis.
Placebo
One capsule daily for up to 36 months.
Locations (191)
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
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
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
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York, United States
NYU Langone Health
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
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
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
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
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
The First Affiliated Hospital of PLA Air Force Medical University
Xi'an, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang, China
Henan Provincial People's Hospital
Zhengzhou, China
The Third People's Hospital of Zhenjiang
Zhenjiang, China
Fakultni nemocnice Ostrava
Ostrava, Czechia
RESEARCH Site s.r.o
Pilsen, Czechia
Aarhus Universitetshospital
Aarhus, Denmark
Hôpital Claude Huriez-Lille-1 Place de Verdun
Lille, France
Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
Lyon, France
CHU-Montpellier-Hopital St Eloi
Montipellier, France
Hopital Saint Antoine, Assistance Publique-Hopitaux de Paris
Paris, France
AP-HP Hopital Henri Mondor
Paris, France
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, France
CHRU de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, France
Charité Campus Virchow-Klinikum-Augustenburger Platz 1
Berlin, Germany
Universitatsklinikum des Saarlandes
Homburg, Germany
Gastroenterologisch - Hepatologisches MVZ Kiel GmbH
Kiel, Germany
Evangelismos General Hospital
Athens, Greece
University General Hospital of Larissa
Larissa, Greece
General Hospital of Thessaloniki ''Hippokratio''
Thessaloniki, Greece
Prince of Wales Hospital - Hong Kong
Hong Kong, Hong Kong
Queen Mary Hospital - PPDS
Hong Kong, Hong Kong
Princess Margaret Hospital - Hong Kong
Hong Kong, Hong Kong
Semmelweis Egyetem - Sebészeti,
Budapest, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, Hungary
Lady Davis Carmel Medical Center
Haifa, Israel
Liver Unit, institute of Gasteroenterology and Liver Diseases
Jerusalem, Israel
Azienda Ospedaliero Universitaria delle Marche -Umberto I G.M. Lancisi G. Salesi
Ancona, Italy
IRCCS Saverio de Bellis-UOSD "Epatopatie"
Castellana Grotte, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy
ASST Santi Paolo Carlo, S.C. Medicina ad Indirizzo Epatologico e Gastroenterologico
Milan, Italy
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Modena, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
A.O.U.P. Paolo Giaccone , U.O.C di Gastroeneterologia
Palermo, Italy
A.O.U. Pisana, U.O. Epatologia
Pisa, Italy
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Italy
Clinica de Higado y Gastroenterologia Integral, S.C.
Cuernavaca, Mexico
PROACTIVE CR MEXICO SA de CV
Irapuato, Mexico
Consultorio Medico - Distrito Federal
Mexico City, Mexico
Centro De Investigacion Y Gastroenterogia, S.C.
México, Mexico
Oaxaca Site Management Organization - Hospital - OSMO - PPDS
Oaxaca City, Mexico
FAICIC
Veracruz, Mexico
ID Clinic Arkadiusz Pisula
Mysłowice, Poland
PlanetMed SP. z. o. o
Wroclaw, Poland
Institutul Clinic Fundeni
Bucharest, Romania
National University Hospital
Singapore, Singapore
Singapore General Hospital (SGH)
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
Changi General Hospital
Singapore, Singapore
Pusan National University Hospital
Busan, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Complexo Hospitalario Universitario De Santiago
A Coruña, Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitario Vall d'Hebron-VIHR
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
C.H. Regional Reina Sofia - PPDS
Córdoba, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Marques de Valdecilla
Santander, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain
Universitätsspital Bern
Bern, Switzerland
Universitätsspital Zürich
Zurich, Switzerland
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, Taiwan
Adana City Training and Research Hospital
Adana, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital
Gaziantep, Turkey (Türkiye)
Uludag University Medical Faculty
Görükle, Turkey (Türkiye)
Ege University
Izmir, Turkey (Türkiye)
Katip Celebi University
Karabağlar, Turkey (Türkiye)
Kocaeli University Medical Faculty Hospital
Kocaeli, Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, Turkey (Türkiye)
Marmara University Pendik Training and Research Hospital
Pendik, Turkey (Türkiye)
Rize Recep Tayyip Erdogan University Training and Research Hospital
Rize Merkez, Turkey (Türkiye)
Hull Royal Infirmary
Hull, United Kingdom
East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital
Ipswich, United Kingdom
The Royal London Hospital
London, United Kingdom
Royal Free Hospital
London, United Kingdom
King's College Hospital
London, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Sheffield teaching hospital NHS foundation trust
Sheffield, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom