Primary Biliary Cholangitis Clinical Trials

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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

Status: Recruiting
Location: See all (189) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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 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)

Locations
United States
Arizona
St. Joseph's Hospital and Medical Center - 350 W. Thomas
RECRUITING
Phoenix
California
OM Research LLC
RECRUITING
Lancaster
Cedar Sinai Medical Center
RECRUITING
Los Angeles
SCPMG/Kaiser Permanente Los Angeles Medical Center
RECRUITING
Los Angeles
California Liver Research Institute
RECRUITING
Pasadena
Stanford University
RECRUITING
Redwood City
University of California, Davis Medical Center
RECRUITING
Sacramento
California Pacific Medical Center - Sutter Pacific Medical Foundation
RECRUITING
San Francisco
Connie Frank Transplant Center at UCSF
RECRUITING
San Francisco
Florida
Covenant Metabolic Specialists, LLC
RECRUITING
Fort Myers
Schiff Center for Liver Diseases/University of Miami
RECRUITING
Miami
Covenant Metabolic Specialists, LLC
RECRUITING
Sarasota
Florida Research Institute
RECRUITING
Tampa
Georgia
Piedmont Atlanta Hospital / Piedmont Transplant Institute
RECRUITING
Atlanta
Iowa
University Of Iowa Hospitals And Clinics
RECRUITING
Iowa City
Illinois
Northwestern University
RECRUITING
Chicago
University of Chicago Medical Center
RECRUITING
Chicago
Kentucky
University of Louisville, Clinical Trials Unit
RECRUITING
Louisville
Louisiana
Ochsner Clinic Foundation
RECRUITING
Jefferson
University Health System - East Jefferson General Hospital Campus
RECRUITING
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Mercy Medical Center
RECRUITING
Baltimore
Walter Reed National Military
RECRUITING
Bethesda
Michigan
Henry Ford Medical Center - Columbus
RECRUITING
Detroit
Minnesota
University of Rochester Medical Center - Strong Memorial Hospital
RECRUITING
Rochester
North Carolina
Wake Forest Baptist Medical Center
RECRUITING
Winston-salem
New York
Northwell Health Center for Liver Disease and Transplantation
RECRUITING
Manhasset
Mount Sinai
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Ohio
The Cleveland Clinic Foundation
RECRUITING
Cleveland
University Hosptials Cleveland Medical Center
RECRUITING
Cleveland
The Ohio State University Medical Center
RECRUITING
Columbus
Pennsylvania
Penn State Health Milton S. Hershey Medical Center
RECRUITING
Hershey
Thomas Jefferson University
RECRUITING
Philadelphia
University of Pennsylvania Perelman Center for Advanced Medicine
RECRUITING
Philadelphia
UPMC Center for Liver Diseases
RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Gastro One
RECRUITING
Cordova
Texas
The Liver Institute at Methodist Dallas Medical Center
RECRUITING
Dallas
University of Texas Southwestern Medical Center, Professional Office Building One
RECRUITING
Dallas
Soma Clinical Trials
RECRUITING
Denison
American Research Corporation
RECRUITING
San Antonio
Pinnacle Clinical Research, PLLC
RECRUITING
San Antonio
Virginia
MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax
RECRUITING
Fairfax
Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads
RECRUITING
Newport News
VCU Health Clinical Research Services Unit (CRSU)
RECRUITING
Richmond
Washington
Liver Institute Northwest
RECRUITING
Seattle
Other Locations
Argentina
AES - AS - Glenny Corp. S.A. Buenos Aires
RECRUITING
Buenos Aires
Buenos Aires Mácula
RECRUITING
Buenos Aires
Centro de Investigación y Prevención Cardiovascular
RECRUITING
Buenos Aires
Consultorios Médicos Dr. Doreski - PPDS
RECRUITING
Buenos Aires
Hospital Italiano de Buenos Aires
RECRUITING
Buenos Aires
Higea S.A.
RECRUITING
Mendoza
DIM Clinica Privada
RECRUITING
Ramos Mejía
CINME S.A. - Centro de Investigaciones Metabólicas
RECRUITING
Recoleta
Hospital Provincial Del Centenario
RECRUITING
Rosario
Australia
Flinders Medical Center
RECRUITING
Adelaide
Monash Health, Monash Medical Centre
RECRUITING
Clayton
Northern Health
RECRUITING
Epping
Alfred Hospital
RECRUITING
Melbourne
Princess Alexandra Hospital
RECRUITING
Queensland
Austria
Landeskrankenhaus Hall
RECRUITING
Hall In Tirol
Krankenhaus der Barmherzigen Brüder
RECRUITING
Vienna
Medizinische Universität Wien
RECRUITING
Vienna
Klinikum Wels-Grieskirchen GmbH - Standort Wels
RECRUITING
Wels
Belgium
UZ Antwerpen
RECRUITING
Edegem
UZ Gent
RECRUITING
Ghent
UZ Leuven - PPDS
RECRUITING
Leuven
Canada
University of Calgary
RECRUITING
Calgary
University of Alberta
RECRUITING
Edmonton
Centre Hospitalier de l'Universite de Montreal
RECRUITING
Montreal
Ottawa Hospital
RECRUITING
Ottawa
Diex Recherche - Québec - PPDS
RECRUITING
Québec
Toronto General Hospital
RECRUITING
Toronto
GI Research Institute Foundation
RECRUITING
Vancouver
Chile
Centro de Investigación y Prevención Cardiovascular
RECRUITING
La Serena
BIOCINETIC Ltda
RECRUITING
Santiago
Pontificia Universidad Católica de Chile
RECRUITING
Santiago
Clinical Research Chile SpA - PPDS
RECRUITING
Valdivia
China
Beijing Ditan Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Friendship Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Youan Hospital, Capital Medical University
RECRUITING
Beijing
The First Hospital of Jilin University
RECRUITING
Changchun
West China Hospital of Sichuan University
RECRUITING
Chengdu
The Second Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Mengchao Hepatobiliary Hospital of Fujian Medical University
RECRUITING
Fuzhou
The Third Affiliated Hospital, Sun Yat-Sen University
RECRUITING
Guangzhou
Guizhou Provincial People's Hospital
RECRUITING
Guiyang
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
The First People's Hospital of Yunnan Province
RECRUITING
Kunming
The Second Hospital of Nanjing
RECRUITING
Nanjing
Shanghai Jiaotong University School of Medicine, Renji Hospital
RECRUITING
Shanghai
The First Affiliated Hospital of Xinjiang Medical University
RECRUITING
Ürümqi
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
The First Affiliated Hospital of PLA Air Force Medical University
RECRUITING
Xi'an
The First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Zhejiang
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
The Third People's Hospital of Zhenjiang
RECRUITING
Zhenjiang
Denmark
Aarhus Universitetshospital
RECRUITING
Aarhus
France
Hôpital Claude Huriez-Lille-1 Place de Verdun
RECRUITING
Lille
Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
RECRUITING
Lyon
CHU-Montpellier-Hopital St Eloi
RECRUITING
Montipellier
AP-HP Hopital Henri Mondor
RECRUITING
Paris
Hopital Saint Antoine, Assistance Publique-Hopitaux de Paris
RECRUITING
Paris
CHU de Strasbourg - Nouvel Hôpital Civil
RECRUITING
Strasbourg
CHRU de Nancy - Hôpitaux de Brabois
RECRUITING
Vandœuvre-lès-nancy
Germany
Charité Campus Virchow-Klinikum-Augustenburger Platz 1
RECRUITING
Berlin
Universitatsklinikum des Saarlandes
RECRUITING
Homburg
Gastroenterologisch - Hepatologisches MVZ Kiel GmbH
RECRUITING
Kiel
Greece
Evangelismos General Hospital
RECRUITING
Athens
University General Hospital of Larissa
RECRUITING
Larissa
General Hospital of Thessaloniki ''Hippokratio''
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Prince of Wales Hospital - Hong Kong
RECRUITING
Hong Kong
Princess Margaret Hospital - Hong Kong
RECRUITING
Hong Kong
Queen Mary Hospital - PPDS
RECRUITING
Hong Kong
Hungary
Semmelweis Egyetem - Sebészeti,
RECRUITING
Budapest
Somogy Varmegyei Kaposi Mor Oktato Korhaz
RECRUITING
Kaposvár
Israel
Lady Davis Carmel Medical Center
RECRUITING
Haifa
Liver Unit, institute of Gasteroenterology and Liver Diseases
RECRUITING
Jerusalem
Italy
Azienda Ospedaliero Universitaria delle Marche -Umberto I G.M. Lancisi G. Salesi
RECRUITING
Ancona
IRCCS Saverio de Bellis-UOSD Epatopatie
RECRUITING
Castellana Grotte
ASST Santi Paolo Carlo, S.C. Medicina ad Indirizzo Epatologico e Gastroenterologico
RECRUITING
Milan
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
RECRUITING
Modena
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING
Monza
A.O.U.P. Paolo Giaccone , U.O.C di Gastroeneterologia
RECRUITING
Palermo
A.O.U. Pisana, U.O. Epatologia
RECRUITING
Pisa
Ospedale Casa Sollievo Della Sofferenza IRCCS
RECRUITING
San Giovanni Rotondo
Mexico
Clinica de Higado y Gastroenterologia Integral, S.C.
RECRUITING
Cuernavaca
PROACTIVE CR MEXICO SA de CV
RECRUITING
Irapuato
Centro De Investigacion Y Gastroenterogia, S.C.
RECRUITING
México
Consultorio Medico - Distrito Federal
RECRUITING
Mexico City
Oaxaca Site Management Organization - Hospital - OSMO - PPDS
RECRUITING
Oaxaca City
FAICIC
RECRUITING
Veracruz
Poland
ID Clinic Arkadiusz Pisula
RECRUITING
Mysłowice
PlanetMed SP. z. o. o
RECRUITING
Wroclaw
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Kyungpook National University Hospital
RECRUITING
Daegu
Chonnam National University Hospital
RECRUITING
Gwangju
Seoul National University Bundang Hospital
RECRUITING
Seongnam
Asan Medical Center
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITING
Seoul
Romania
Institutul Clinic Fundeni
RECRUITING
Bucharest
Singapore
Changi General Hospital
RECRUITING
Singapore
National University Hospital
RECRUITING
Singapore
Singapore General Hospital (SGH)
RECRUITING
Singapore
Tan Tock Seng Hospital
RECRUITING
Singapore
Spain
Complexo Hospitalario Universitario De Santiago
RECRUITING
A Coruña
Hospital Universitario Fundacion Alcorcon
RECRUITING
Alcorcón
Hospital Universitario Germans Trias i Pujol
RECRUITING
Badalona
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron-VIHR
RECRUITING
Barcelona
C.H. Regional Reina Sofia - PPDS
RECRUITING
Córdoba
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen del Rocio - PPDS
RECRUITING
Seville
Switzerland
Universitätsspital Bern
RECRUITING
Bern
Universitätsspital Zürich
RECRUITING
Zurich
Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Kaohsiung Medical University Hospital
RECRUITING
Kaohsiung City
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital, Linkou
RECRUITING
Taoyuan District
Turkey
Adana City Training and Research Hospital
RECRUITING
Adana
Ankara Bilkent City Hospital
RECRUITING
Ankara
Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital
RECRUITING
Gaziantep
Uludag University Medical Faculty
RECRUITING
Görükle
Ege University
RECRUITING
Izmir
Katip Celebi University
RECRUITING
Karabağlar
Kocaeli University Medical Faculty Hospital
RECRUITING
Kocaeli
Mersin Universitesi Tip Fakultesi Hastanesi
RECRUITING
Mersin
Marmara University Pendik Training and Research Hospital
RECRUITING
Pendik
Rize Recep Tayyip Erdogan University Training and Research Hospital
RECRUITING
Rize Merkez
United Kingdom
Hull Royal Infirmary
RECRUITING
Hull
East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital
RECRUITING
Ipswich
King's College Hospital
RECRUITING
London
Royal Free Hospital
RECRUITING
London
The Royal London Hospital
RECRUITING
London
Freeman Hospital
RECRUITING
Newcastle Upon Tyne
John Radcliffe Hospital
RECRUITING
Oxford
Sheffield teaching hospital NHS foundation trust
RECRUITING
Sheffield
New Cross Hospital
RECRUITING
Wolverhampton
Contact Information
Primary
Gilead Clinical Study Information Center
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Time Frame
Start Date: 2023-09-07
Estimated Completion Date: 2030-08
Participants
Target number of participants: 318
Treatments
Experimental: Seladelpar
Placebo_comparator: Placebo
Sponsors
Leads: Gilead Sciences

This content was sourced from clinicaltrials.gov

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