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

April 28, 2026 updated by: Gilead Sciences

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

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

Study Overview

Status

Recruiting

Conditions

Primary Biliary Cholangitis

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

318

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Gilead Clinical Study Information Center
Phone Number: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com

Study Locations

Argentina
- - Buenos Aires, Argentina, 1181
    - Recruiting
    - Hospital Italiano de Buenos Aires
  - Buenos Aires, Argentina, C1430
    - Recruiting
    - AES - AS - Glenny Corp. S.A. Buenos Aires
  - Buenos Aires, Argentina, 1426
    - Recruiting
    - Consultorios Médicos Dr. Doreski - PPDS
  - Buenos Aires, Argentina, C1061
    - Recruiting
    - Buenos Aires Mácula
  - Buenos Aires, Argentina, C1061
    - Recruiting
    - Centro de Investigación y Prevención Cardiovascular
  - Mendoza, Argentina, M5500
    - Recruiting
    - Higea S.A.
  - Ramos Mejía, Argentina, 1704
    - Recruiting
    - DIM Clínica Privada
  - Recoleta, Argentina, C1118AAT
    - Recruiting
    - CINME S.A. - Centro de Investigaciones Metabólicas
  - Rosario, Argentina, 2000
    - Recruiting
    - Hospital Provincial del Centenario
Australia
- Queensland
  - Queensland, Queensland, Australia, 4102
    - Recruiting
    - Princess Alexandra Hospital
- South Australia
  - Adelaide, South Australia, Australia, 5042
    - Recruiting
    - Flinders Medical Center
- Victoria
  - Clayton, Victoria, Australia, 3168
    - Recruiting
    - Monash Health, Monash Medical Centre
  - Epping, Victoria, Australia, 3076
    - Recruiting
    - Northern Health
  - Melbourne, Victoria, Australia, 3004
    - Recruiting
    - Alfred Hospital
Austria
- - Hall in Tirol, Austria, 6060
    - Recruiting
    - Landeskrankenhaus Hall
  - Vienna, Austria, 1090
    - Recruiting
    - Medizinische Universität Wien
  - Vienna, Austria, 1020
    - Recruiting
    - Krankenhaus der Barmherzigen Brüder
  - Wels, Austria, 4600
    - Recruiting
    - Klinikum Wels-Grieskirchen GmbH - Standort Wels
Belgium
- - Edegem, Belgium, 2650
    - Recruiting
    - UZ Antwerpen
  - Ghent, Belgium, 9000
    - Recruiting
    - UZ Gent
  - Leuven, Belgium, 3000
    - Recruiting
    - UZ Leuven - PPDS
Canada
- - Calgary, Canada, T2N 4Z6
    - Recruiting
    - University of Calgary
  - Edmonton, Canada, T6G 2B7
    - Recruiting
    - University of Alberta
  - Montreal, Canada, H2L 4M1
    - Recruiting
    - Centre Hospitalier de L'Universite de Montreal
  - Ottawa, Canada, K1H 8L6
    - Recruiting
    - Ottawa Hospital
  - Québec, Canada, G1V 4T3
    - Recruiting
    - Diex Recherche - Québec - PPDS
  - Toronto, Canada, M5G 2C4
    - Recruiting
    - Toronto General Hospital
  - Vancouver, Canada, V6G 2Z6
    - Recruiting
    - GI Research Institute Foundation
Chile
- - La Serena, Chile, 1720506
    - Recruiting
    - Centro de Investigación y Prevención Cardiovascular
  - Santiago, Chile, 8320000
    - Recruiting
    - Pontificia Universidad Catolica de Chile
  - Santiago, Chile, 8330336
    - Recruiting
    - Biocinetic Ltda
  - Valdivia, Chile, 5110683
    - Recruiting
    - Clinical Research Chile SpA - PPDS
China
- - Beijing, China, 100050
    - Recruiting
    - Beijing Friendship Hospital, Capital Medical University
  - Beijing, China, 100000
    - Recruiting
    - Beijing Youan Hospital, Capital Medical University
  - Beijing, China, 100015
    - Recruiting
    - Beijing Ditan Hospital, Capital Medical University
  - Changchun, China, 130021
    - Recruiting
    - The First Hospital of Jilin University
  - Chengdu, China, 610047
    - Recruiting
    - West China Hospital of Sichuan University
  - Chongqing, China, 401336
    - Recruiting
    - The Second Affiliated Hospital of Chongqing Medical University
  - Fuzhou, China
    - Recruiting
    - Mengchao Hepatobiliary Hospital of FuJian Medical University
  - Guangzhou, China, 510630
    - Recruiting
    - The Third Affiliated Hospital, Sun Yat-Sen University
  - Guiyang, China, 550002
    - Recruiting
    - Guizhou Provincial People's Hospital
  - Hefei, China, 230032
    - Recruiting
    - The First Affiliated Hospital of Anhui Medical University
  - Kunming, China, 650032
    - Recruiting
    - The First People's Hospital of Yunnan Province
  - Nanjing, China, 210003
    - Recruiting
    - The Second Hospital of Nanjing
  - Shanghai, China, 200001
    - Recruiting
    - Shanghai Jiaotong University School of Medicine, Renji Hospital
  - Wuhan, China, 430030
    - Recruiting
    - Union Hospital Tongji Medical College Huazhong University of Science and Technology
  - Xi'an, China, 710061
    - Recruiting
    - The First Affiliated Hospital of Xi'an Jiaotong University
  - Xi'an, China, 710032
    - Recruiting
    - The First Affiliated Hospital of PLA Air Force Medical University
  - Zhejiang, China, 310009
    - Recruiting
    - The First Affiliated Hospital, Zhejiang University School of Medicine
  - Zhengzhou, China, 450003
    - Recruiting
    - Henan Provincial People's Hospital
  - Zhenjiang, China, 212021
    - Recruiting
    - The Third People's Hospital of Zhenjiang
  - Ürümqi, China, 830054
    - Recruiting
    - The First Affiliated Hospital of Xinjiang Medical University
Czechia
- - Ostrava, Czechia, 70852
    - Recruiting
    - Fakultni nemocnice Ostrava
  - Pilsen, Czechia, 301 00
    - Recruiting
    - RESEARCH Site s.r.o
Denmark
- - Aarhus, Denmark, 8200
    - Recruiting
    - Aarhus Universitetshospital
France
- - Bobigny, France, 93000
    - Recruiting
    - AP-HP - Hopital Avicenne
  - Lille, France, 59000
    - Recruiting
    - Hôpital Claude Huriez-Lille-1 Place de Verdun
  - Lyon, France, 69317
    - Recruiting
    - Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
  - Montipellier, France, 34295
    - Recruiting
    - CHU-Montpellier-Hopital St Eloi
  - Paris, France, 75012
    - Recruiting
    - Hopital Saint Antoine, Assistance Publique-Hopitaux de Paris
  - Paris, France, 94000
    - Recruiting
    - AP-HP Hôpital Henri Mondor
  - Strasbourg, France, 67000
    - Recruiting
    - CHU de Strasbourg - Nouvel Hopital Civil
  - Vandœuvre-lès-Nancy, France, 54500
    - Recruiting
    - CHRU de Nancy - Hopitaux de Brabois
Germany
- - Berlin, Germany, 13353
    - Recruiting
    - Charite Campus Virchow-Klinikum-Augustenburger Platz 1
  - Homburg, Germany, 66421
    - Recruiting
    - Universitätsklinikum des Saarlandes
  - Kiel, Germany, 24146
    - Recruiting
    - Gastroenterologisch - Hepatologisches MVZ Kiel GmbH
Greece
- - Athens, Greece, 106 76
    - Recruiting
    - Evangelismos General Hospital
  - Larissa, Greece, 41 110
    - Recruiting
    - University General Hospital of Larissa
  - Thessaloniki, Greece, 546 41
    - Recruiting
    - General Hospital of Thessaloniki ''Hippokratio''
Hong Kong
- - Hong Kong, Hong Kong, 999077
    - Recruiting
    - Queen Mary Hospital - PPDS
  - Hong Kong, Hong Kong, 000
    - Recruiting
    - Prince of Wales Hospital - Hong Kong
  - Hong Kong, Hong Kong
    - Recruiting
    - Princess Margaret Hospital - Hong Kong
Hungary
- - Budapest, Hungary, 1082
    - Recruiting
    - Semmelweis Egyetem - Sebészeti,
  - Kaposvár, Hungary, 7400
    - Recruiting
    - Somogy Vármegyei Kaposi Mór Oktató Kórház
Israel
- - Beersheba, Israel, 84101
    - Recruiting
    - Soroka University Medical Centre
  - Haifa, Israel, 33394
    - Recruiting
    - Lady Davis Carmel Medical Center
  - Jerusalem, Israel, 91120
    - Recruiting
    - Liver Unit, institute of Gasteroenterology and Liver Diseases
  - Tel Aviv, Israel, 64239
    - Recruiting
    - Tel Aviv Sourasky Medical Center Ichilov
Italy
- - Ancona, Italy, 60020
    - Recruiting
    - Azienda Ospedaliero Universitaria delle Marche -Umberto I G.M. Lancisi G. Salesi
  - Castellana Grotte, Italy, 70013
    - Recruiting
    - IRCCS Saverio de Bellis-UOSD "Epatopatie"
  - Milan, Italy, 20122
    - Recruiting
    - Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  - Milan, Italy, 20142
    - Recruiting
    - ASST Santi Paolo Carlo, S.C. Medicina ad Indirizzo Epatologico e Gastroenterologico
  - Modena, Italy, 41126
    - Recruiting
    - Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
  - Monza, Italy, 20052
    - Recruiting
    - Fondazione IRCCS San Gerardo dei Tintori
  - Palermo, Italy, 90127
    - Recruiting
    - A.O.U.P. Paolo Giaccone , U.O.C di Gastroeneterologia
  - Pisa, Italy, 56124
    - Recruiting
    - A.O.U. Pisana, U.O. Epatologia
  - San Giovanni Rotondo, Italy, 71013
    - Recruiting
    - Ospedale Casa Sollievo Della Sofferenza IRCCS
Mexico
- - Cuernavaca, Mexico, 62170
    - Recruiting
    - Clinica de Higado y Gastroenterologia Integral, S.C.
  - Irapuato, Mexico, 36650
    - Recruiting
    - Proactive CR México SA de CV
  - Mexico City, Mexico, 6700
    - Recruiting
    - Consultorio Medico - Distrito Federal
  - México, Mexico, 76806
    - Recruiting
    - Centro De Investigacion Y Gastroenterogia, S.C.
  - Oaxaca City, Mexico, 71256
    - Recruiting
    - Oaxaca Site Management Organization - Hospital - OSMO - PPDS
  - Veracruz, Mexico, 91900
    - Recruiting
    - FAICIC
Poland
- - Mysłowice, Poland, 41-400
    - Recruiting
    - ID Clinic Arkadiusz Pisula
  - Wroclaw, Poland, 52-210
    - Recruiting
    - PlanetMed SP. z. o. o
Puerto Rico
- - Manati, Puerto Rico, 00674
    - Recruiting
    - Galenus Group - Puerto Rico
Romania
- - Bucharest, Romania, 022328
    - Recruiting
    - Institutul Clinic Fundeni
Singapore
- - Singapore, Singapore, 308433
    - Recruiting
    - Tan Tock Seng Hospital
  - Singapore, Singapore, 119228
    - Recruiting
    - National University Hospital
  - Singapore, Singapore, 529889
    - Recruiting
    - Changi General Hospital
  - Singapore, Singapore, 308433
    - Recruiting
    - Singapore General Hospital (SGH)
South Korea
- - Busan, South Korea, 49241
    - Recruiting
    - Pusan National University Hospital
  - Daegu, South Korea, 41944
    - Recruiting
    - Kyungpook National University Hospital
  - Gwangju, South Korea, 61455
    - Recruiting
    - Chonnam National University Hospital
  - Seongnam, South Korea, 13620
    - Recruiting
    - Seoul National University Bundang Hospital
  - Seoul, South Korea, 05505
    - Recruiting
    - Asan Medical Center
  - Seoul, South Korea, 6351
    - Recruiting
    - Samsung Medical Center
  - Seoul, South Korea, 6591
    - Recruiting
    - The Catholic University of Korea, Seoul ST. Mary's Hospital
  - Seoul, South Korea, 08308
    - Recruiting
    - Korea University Guro Hospital
  - Seoul, South Korea, 3722
    - Recruiting
    - Severance Hospital, Yonsei University Health System
  - Seoul, South Korea, 3080
    - Recruiting
    - Seoul National University Hospital
Spain
- - A Coruña, Spain, 15706
    - Recruiting
    - Complexo Hospitalario Universitario De Santiago
  - Alcorcón, Spain, 28925
    - Recruiting
    - Hospital Universitario Fundación Alcorcón
  - Badalona, Spain, 08916
    - Recruiting
    - Hospital Universitario Germans Trias i Pujol
  - Barcelona, Spain, 08003
    - Recruiting
    - Hospital del Mar
  - Barcelona, Spain, 08036
    - Recruiting
    - Hospital Clínic de Barcelona
  - Barcelona, Spain, 08035
    - Recruiting
    - Hospital Universitario Vall d'Hebron-VIHR
  - Córdoba, Spain, 14004
    - Recruiting
    - C.H. Regional Reina Sofia - PPDS
  - Málaga, Spain, 29010
    - Recruiting
    - Hospital Universitario Virgen de la Victoria
  - Santander, Spain, 39008
    - Recruiting
    - Hospital Universitario Marques de Valdecilla
  - Seville, Spain, 41010
    - Recruiting
    - Hospital Universitario Virgen del Rocio - PPDS
Switzerland
- - Bern, Switzerland, 3010
    - Recruiting
    - Universitätsspital Bern
  - Zurich, Switzerland, 8091
    - Recruiting
    - Universitätsspital Zürich
Taiwan
- - Kaohsiung City, Taiwan, 83301
    - Recruiting
    - Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
  - Kaohsiung City, Taiwan, 80756
    - Recruiting
    - Kaohsiung Medical University Hospital
  - Tainan, Taiwan, 70403
    - Recruiting
    - National Cheng Kung University Hospital
  - Taipei, Taiwan, 10002
    - Recruiting
    - National Taiwan University Hospital
  - Taipei, Taiwan, 112
    - Recruiting
    - Taipei Veterans General Hospital
  - Taoyuan, Taiwan, 33305
    - Recruiting
    - Chang Gung Memorial Hospital, Linkou
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 1370
    - Recruiting
    - Adana City Training and Research Hospital
  - Ankara, Turkey (Türkiye), 06800
    - Recruiting
    - Ankara Bilkent City Hospital
  - Gaziantep, Turkey (Türkiye), 27630
    - Recruiting
    - Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital
  - Görükle, Turkey (Türkiye), 16059
    - Recruiting
    - Uludag University Medical Faculty
  - Izmir, Turkey (Türkiye), 35040
    - Recruiting
    - Ege University
  - Karabağlar, Turkey (Türkiye), 35150
    - Recruiting
    - Katip Celebi University
  - Kocaeli, Turkey (Türkiye), 41380
    - Recruiting
    - Kocaeli University Medical Faculty Hospital
  - Mersin, Turkey (Türkiye), 33110
    - Recruiting
    - Mersin Universitesi Tip Fakultesi Hastanesi
  - Pendik, Turkey (Türkiye), 34899
    - Recruiting
    - Marmara University Pendik Training and Research Hospital
  - Rize Merkez, Turkey (Türkiye), 53020
    - Recruiting
    - Rize Recep Tayyip Erdogan University Training and Research Hospital
United Kingdom
- - Hull, United Kingdom, HU32JZ
    - Recruiting
    - Hull Royal Infirmary
  - Ipswich, United Kingdom, IP4 5PD
    - Recruiting
    - East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital
  - London, United Kingdom, SE5 9RS
    - Recruiting
    - King's College Hospital
  - London, United Kingdom, E1 1BB
    - Recruiting
    - The Royal London Hospital
  - London, United Kingdom, NW2 2QG
    - Recruiting
    - Royal Free Hospital
  - Newcastle upon Tyne, United Kingdom, NE7 7DN
    - Recruiting
    - Freeman Hospital
  - Oxford, United Kingdom, OX3 9DU
    - Recruiting
    - John Radcliffe Hospital
  - Sheffield, United Kingdom, S10 2JF
    - Recruiting
    - Sheffield teaching hospital NHS foundation trust
  - Wolverhampton, United Kingdom, WV10 0QP
    - Recruiting
    - New Cross Hospital
United States
- Arizona
  - Phoenix, Arizona, United States, 85013
    - Recruiting
    - St. Joseph's Hospital and Medical Center - 350 W. Thomas
- California
  - Lancaster, California, United States, 93534
    - Recruiting
    - Om Research LLC
  - Los Angeles, California, United States, 90027
    - Recruiting
    - SCPMG/Kaiser Permanente Los Angeles Medical Center
  - Los Angeles, California, United States, 90048
    - Recruiting
    - Cedar Sinai Medical Center
  - Pasadena, California, United States, 91105
    - Recruiting
    - California Liver Research Institute
  - Redwood City, California, United States, 94063
    - Recruiting
    - Stanford University
  - Sacramento, California, United States, 95817
    - Recruiting
    - University of California, Davis Medical Center
  - San Francisco, California, United States, 94143
    - Recruiting
    - Connie Frank Transplant Center at UCSF
  - San Francisco, California, United States, 94109
    - Recruiting
    - California Pacific Medical Center - Sutter Pacific Medical Foundation
- Florida
  - Fort Myers, Florida, United States, 33912
    - Recruiting
    - Covenant Metabolic Specialists, LLC
  - Miami, Florida, United States, 33136
    - Recruiting
    - Schiff Center for Liver Diseases/University of Miami
  - Sarasota, Florida, United States, 33912
    - Recruiting
    - Covenant Metabolic Specialists, LLC
  - Tampa, Florida, United States, 34211
    - Recruiting
    - Florida Research Institute
- Georgia
  - Atlanta, Georgia, United States, 30309
    - Recruiting
    - Piedmont Atlanta Hospital / Piedmont Transplant Institute
- Illinois
  - Chicago, Illinois, United States, 60637
    - Recruiting
    - University of Chicago Medical Center
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - Northwestern University
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Recruiting
    - University of Iowa Hospitals and Clinics
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - University of Louisville, Clinical Trials Unit
- Louisiana
  - Jefferson, Louisiana, United States, 70121
    - Recruiting
    - Ochsner Clinic Foundation
  - New Orleans, Louisiana, United States, 70112
    - Recruiting
    - University Health System - East Jefferson General Hospital Campus
- Maryland
  - Baltimore, Maryland, United States, 21202
    - Recruiting
    - Mercy Medical Center
  - Bethesda, Maryland, United States, 20889
    - Recruiting
    - Walter Reed National Military
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Recruiting
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Beth Israel Deaconess Medical Center
- Michigan
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Henry Ford Medical Center - Columbus
- Minnesota
  - Rochester, Minnesota, United States, 14642
    - Recruiting
    - University of Rochester Medical Center - Strong Memorial Hospital
- New York
  - Manhasset, New York, United States, 11030
    - Recruiting
    - Northwell Health Center for Liver Disease and Transplantation
  - New York, New York, United States, 10016
    - Recruiting
    - NYU Langone Health
  - New York, New York, United States, 10029
    - Recruiting
    - Mount Sinai
- North Carolina
  - Winston-Salem, North Carolina, United States, 27157
    - Recruiting
    - Wake Forest Baptist Medical Center
    - Contact:
      
      Wake FBM Center
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Recruiting
    - The Cleveland Clinic Foundation
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - University Hosptials Cleveland Medical Center
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - The Ohio State University Medical Center
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Recruiting
    - Penn State Health Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - University of Pennsylvania Perelman Center for Advanced Medicine
  - Philadelphia, Pennsylvania, United States, 19107
    - Recruiting
    - Thomas Jefferson University
  - Pittsburgh, Pennsylvania, United States, 15213
    - Recruiting
    - UPMC Center for Liver Diseases
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Medical University of South Carolina
- Tennessee
  - Cordova, Tennessee, United States, 38018
    - Recruiting
    - Gastro One
- Texas
  - Dallas, Texas, United States, 75203
    - Recruiting
    - The Liver Institute at Methodist Dallas Medical Center
  - Dallas, Texas, United States, 75390
    - Recruiting
    - University of Texas Southwestern Medical Center, Professional Office Building One
  - Denison, Texas, United States, 75020
    - Recruiting
    - Soma Clinical Trials
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Pinnacle Clinical Research, PLLC
  - San Antonio, Texas, United States, 78215
    - Recruiting
    - American Research Corporation
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax
  - Newport News, Virginia, United States, 23602
    - Recruiting
    - Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads
  - Richmond, Virginia, United States, 23298
    - Recruiting
    - VCU Health Clinical Research Services Unit (CRSU)
- Washington
  - Seattle, Washington, United States, 98105
    - Recruiting
    - Liver Institute Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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)

Exclusion Criteria:

Individuals must not meet any of the following criteria to be eligible for study participation:

Prior exposure to seladelpar
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.
Decompensated cirrhosis
Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
Hospitalization for liver-related complication within 12 weeks of Screening
Laboratory parameters at Screening:
1. Alkaline phosphatase (ALP) < 1.5× Upper limit of normal (ULN) or ≥ 10×ULN
2. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN
3. Total bilirubin (TB) ≤ 0.6 × ULN or ≥ 5 × ULN
4. Platelet count ≤50×10^3/µL
5. Albumin ≤2.8 g/dL
6. Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m^2
7. 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.
8. Serum alpha-fetoprotein (AFP) >20 ng/mL
9. INR >1.7
CP-C cirrhosis
History or presence of other concomitant liver diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo One capsule daily for up to 36 months.
Experimental: Seladelpar	Drug: 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. Other Names: Livdelzi®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event Free Survival (EFS) Time Frame: 36 months	EFS as measured by the time from start of treatment to the first occurrence of any of the following clinical events: Death by any cause; Liver transplantation; MELD score ≥15; Ascites requiring treatment; Hospitalization for any of the following: Esophageal or gastric variceal bleeding Hepatic encephalopathy Spontaneous bacterial peritonitis	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival Time Frame: 36 months	Time from start of treatment to death from any cause.	36 months
Liver transplant-free survival Time Frame: 36 months	Time from start of treatment to the first occurrence of liver-related death or liver transplantation.	36 months
Time to hospitalization Time Frame: 36 months	Time from start of treatment to the first occurrence of hospitalization for qualifying PBC clinical events	36 months
Time to Event Free Survival (EFS) Time Frame: 36 months	MELD score ≥15 Ascites requiring treatment	36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Investigators

Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Gilead Clinical Trials Website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2023

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CB8025-41837
2024-516525-31-00 (Other Identifier: EU Trial (CTIS) Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Primary Biliary Cholangitis

Clinical Trials on Placebo

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