Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
AFFIRM
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
2 other identifiers
interventional
318
27 countries
192
Brief Summary
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2023
Longer than P75 for phase_3
192 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 7, 2023
CompletedFirst Submitted
Initial submission to the registry
September 18, 2023
CompletedFirst Posted
Study publicly available on registry
September 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
April 30, 2026
April 1, 2026
6.9 years
September 18, 2023
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event Free Survival (EFS)
EFS as measured by the time from start of treatment to the first occurrence of any of the following clinical events: 1. Death by any cause; 2. Liver transplantation; 3. MELD score ≥15; 4. Ascites requiring treatment; 5. Hospitalization for any of the following: 1. Esophageal or gastric variceal bleeding 2. Hepatic encephalopathy 3. Spontaneous bacterial peritonitis
36 months
Secondary Outcomes (4)
Overall survival
36 months
Liver transplant-free survival
36 months
Time to hospitalization
36 months
Time to Event Free Survival (EFS)
36 months
Study Arms (2)
Seladelpar
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
* 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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (196)
St. Joseph's Hospital and Medical Center - 350 W. Thomas
Phoenix, Arizona, 85013, United States
OM Research LLC
Lancaster, California, 93534, United States
SCPMG/Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Cedar Sinai Medical Center
Los Angeles, California, 90048, United States
California Liver Research Institute
Pasadena, California, 91105, United States
Stanford University
Redwood City, California, 94063, United States
University of California, Davis Medical Center
Sacramento, California, 95817, United States
California Pacific Medical Center - Sutter Pacific Medical Foundation
San Francisco, California, 94109, United States
Connie Frank Transplant Center at UCSF
San Francisco, California, 94143, United States
Covenant Metabolic Specialists, LLC
Fort Myers, Florida, 33912, United States
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, 33136, United States
Covenant Metabolic Specialists, LLC
Sarasota, Florida, 33912, United States
Florida Research Institute
Tampa, Florida, 34211, United States
Piedmont Atlanta Hospital / Piedmont Transplant Institute
Atlanta, Georgia, 30309, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242, United States
University of Louisville, Clinical Trials Unit
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
Jefferson, Louisiana, 70121, United States
University Health System - East Jefferson General Hospital Campus
New Orleans, Louisiana, 70112, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Walter Reed National Military
Bethesda, Maryland, 20889, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Medical Center - Columbus
Detroit, Michigan, 48202, United States
University of Rochester Medical Center - Strong Memorial Hospital
Rochester, Minnesota, 14642, United States
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York, 11030, United States
NYU Langone Health
New York, New York, 10016, United States
Mount Sinai
New York, New York, 10029, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
University Hosptials Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
UPMC Center for Liver Diseases
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Gastro One
Cordova, Tennessee, 38018, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
University of Texas Southwestern Medical Center, Professional Office Building One
Dallas, Texas, 75390, United States
Soma Clinical Trials
Denison, Texas, 75020, United States
American Research Corporation
San Antonio, Texas, 78215, United States
Pinnacle Clinical Research, PLLC
San Antonio, Texas, 78229, United States
MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax
Fairfax, Virginia, 22031, United States
Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, 23602, United States
VCU Health Clinical Research Services Unit (CRSU)
Richmond, Virginia, 23298, United States
Liver Institute Northwest
Seattle, Washington, 98105, United States
Hospital Italiano de Buenos Aires
Buenos Aires, 1181, Argentina
Consultorios Médicos Dr. Doreski - PPDS
Buenos Aires, 1426, Argentina
Buenos Aires Mácula
Buenos Aires, C1061, Argentina
Centro de Investigación y Prevención Cardiovascular
Buenos Aires, C1061, Argentina
AES - AS - Glenny Corp. S.A. Buenos Aires
Buenos Aires, C1430, Argentina
Higea S.A.
Mendoza, M5500, Argentina
DIM Clinica Privada
Ramos Mejía, 1704, Argentina
CINME S.A. - Centro de Investigaciones Metabólicas
Recoleta, C1118AAT, Argentina
Hospital Provincial Del Centenario
Rosario, 2000, Argentina
Princess Alexandra Hospital
Queensland, Queensland, 4102, Australia
Flinders Medical Center
Adelaide, South Australia, 5042, Australia
Monash Health, Monash Medical Centre
Clayton, Victoria, 3168, Australia
Northern Health
Epping, Victoria, 3076, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Landeskrankenhaus Hall
Hall in Tirol, 6060, Austria
Krankenhaus der Barmherzigen Brüder
Vienna, 1020, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Klinikum Wels-Grieskirchen GmbH - Standort Wels
Wels, 4600, Austria
UZ Antwerpen
Edegem, 2650, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Leuven - PPDS
Leuven, 3000, Belgium
University of Calgary
Calgary, T2N 4Z6, Canada
University of Alberta
Edmonton, T6G 2B7, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, H2L 4M1, Canada
Ottawa Hospital
Ottawa, K1H 8L6, Canada
Diex Recherche - Québec - PPDS
Québec, G1V 4T3, Canada
Toronto General Hospital
Toronto, M5G 2C4, Canada
GI Research Institute Foundation
Vancouver, V6G 2Z6, Canada
Centro de Investigación y Prevención Cardiovascular
La Serena, 1720506, Chile
Pontificia Universidad Católica de Chile
Santiago, 8320000, Chile
BIOCINETIC Ltda
Santiago, 8330336, Chile
Clinical Research Chile SpA - PPDS
Valdivia, 5110683, Chile
Beijing Youan Hospital, Capital Medical University
Beijing, 100000, China
Beijing Ditan Hospital, Capital Medical University
Beijing, 100015, China
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050, China
The First Hospital of Jilin University
Changchun, 130021, China
West China Hospital of Sichuan University
Chengdu, 610047, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, 401336, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, China
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, 510630, China
Guizhou Provincial People's Hospital
Guiyang, 550002, China
The First Affiliated Hospital of Anhui Medical University
Hefei, 230032, China
The First People's Hospital of Yunnan Province
Kunming, 650032, China
The Second Hospital of Nanjing
Nanjing, 210003, China
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, 200001, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, 830054, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430030, China
The First Affiliated Hospital of PLA Air Force Medical University
Xi'an, 710032, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang, 310009, China
Henan Provincial People's Hospital
Zhengzhou, 450003, China
The Third People's Hospital of Zhenjiang
Zhenjiang, 212021, China
Fakultni nemocnice Ostrava
Ostrava, 70852, Czechia
RESEARCH Site s.r.o
Pilsen, 301 00, Czechia
Aarhus Universitetshospital
Aarhus, 8200, Denmark
AP-HP - Hopital Avicenne
Bobigny, 93000, France
Hôpital Claude Huriez-Lille-1 Place de Verdun
Lille, 59000, France
Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
Lyon, 69317, France
CHU-Montpellier-Hopital St Eloi
Montipellier, 34295, France
Hopital Saint Antoine, Assistance Publique-Hopitaux de Paris
Paris, 75012, France
AP-HP Hopital Henri Mondor
Paris, 94000, France
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, 67000, France
CHRU de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54500, France
Charité Campus Virchow-Klinikum-Augustenburger Platz 1
Berlin, 13353, Germany
Universitatsklinikum des Saarlandes
Homburg, 66421, Germany
Gastroenterologisch - Hepatologisches MVZ Kiel GmbH
Kiel, 24146, Germany
Evangelismos General Hospital
Athens, 106 76, Greece
University General Hospital of Larissa
Larissa, 41 110, Greece
General Hospital of Thessaloniki ''Hippokratio''
Thessaloniki, 546 41, Greece
Prince of Wales Hospital - Hong Kong
Hong Kong, 000, Hong Kong
Queen Mary Hospital - PPDS
Hong Kong, 999077, Hong Kong
Princess Margaret Hospital - Hong Kong
Hong Kong, Hong Kong
Semmelweis Egyetem - Sebészeti,
Budapest, 1082, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400, Hungary
Soroka University Medical Centre
Beersheba, 84101, Israel
Lady Davis Carmel Medical Center
Haifa, 33394, Israel
Liver Unit, institute of Gasteroenterology and Liver Diseases
Jerusalem, 91120, Israel
Tel Aviv Sourasky Medical Center Ichilov
Tel Aviv, 64239, Israel
Azienda Ospedaliero Universitaria delle Marche -Umberto I G.M. Lancisi G. Salesi
Ancona, 60020, Italy
IRCCS Saverio de Bellis-UOSD "Epatopatie"
Castellana Grotte, 70013, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
ASST Santi Paolo Carlo, S.C. Medicina ad Indirizzo Epatologico e Gastroenterologico
Milan, 20142, Italy
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Modena, 41126, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20052, Italy
A.O.U.P. Paolo Giaccone , U.O.C di Gastroeneterologia
Palermo, 90127, Italy
A.O.U. Pisana, U.O. Epatologia
Pisa, 56124, Italy
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, 71013, Italy
Clinica de Higado y Gastroenterologia Integral, S.C.
Cuernavaca, 62170, Mexico
PROACTIVE CR MEXICO SA de CV
Irapuato, 36650, Mexico
Consultorio Medico - Distrito Federal
Mexico City, 6700, Mexico
Centro De Investigacion Y Gastroenterogia, S.C.
México, 76806, Mexico
Oaxaca Site Management Organization - Hospital - OSMO - PPDS
Oaxaca City, 71256, Mexico
FAICIC
Veracruz, 91900, Mexico
ID Clinic Arkadiusz Pisula
Mysłowice, 41-400, Poland
PlanetMed SP. z. o. o
Wroclaw, 52-210, Poland
Galenus Group - Puerto Rico
Manati, 00674, Puerto Rico
Institutul Clinic Fundeni
Bucharest, 022328, Romania
National University Hospital
Singapore, 119228, Singapore
Singapore General Hospital (SGH)
Singapore, 308433, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Changi General Hospital
Singapore, 529889, Singapore
Pusan National University Hospital
Busan, 49241, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Chonnam National University Hospital
Gwangju, 61455, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 3722, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 6591, South Korea
Complexo Hospitalario Universitario De Santiago
A Coruña, 15706, Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón, 28925, Spain
Hospital Universitario Germans Trias i Pujol
Badalona, 08916, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitario Vall d'Hebron-VIHR
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
C.H. Regional Reina Sofia - PPDS
Córdoba, 14004, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41010, Spain
Universitätsspital Bern
Bern, 3010, Switzerland
Universitätsspital Zürich
Zurich, 8091, Switzerland
Kaohsiung Medical University Hospital
Kaohsiung City, 80756, Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 33305, Taiwan
Adana City Training and Research Hospital
Adana, 1370, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, 06800, Turkey (Türkiye)
Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital
Gaziantep, 27630, Turkey (Türkiye)
Uludag University Medical Faculty
Görükle, 16059, Turkey (Türkiye)
Ege University
Izmir, 35040, Turkey (Türkiye)
Katip Celebi University
Karabağlar, 35150, Turkey (Türkiye)
Kocaeli University Medical Faculty Hospital
Kocaeli, 41380, Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, 33110, Turkey (Türkiye)
Marmara University Pendik Training and Research Hospital
Pendik, 34899, Turkey (Türkiye)
Rize Recep Tayyip Erdogan University Training and Research Hospital
Rize Merkez, 53020, Turkey (Türkiye)
Hull Royal Infirmary
Hull, HU32JZ, United Kingdom
East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital
Ipswich, IP4 5PD, United Kingdom
The Royal London Hospital
London, E1 1BB, United Kingdom
Royal Free Hospital
London, NW2 2QG, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
Sheffield teaching hospital NHS foundation trust
Sheffield, S10 2JF, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Central Study Contacts
Gilead Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2023
First Posted
September 25, 2023
Study Start
September 7, 2023
Primary Completion (Estimated)
August 1, 2030
Study Completion (Estimated)
August 1, 2030
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share