Primary Biliary CholangitisPhase 3AFFIRMNCT06051617
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
A Phase 3 study testing Seladelpar in people with Primary Biliary Cholangitis, run by Gilead Sciences at 217 sites in 29 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Biliary Cholangitis
- What is being tested?
- Seladelpar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 217 sitesin 29 countries
- Study dates
- 7 Sep 2023to Aug 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 primary biliary cholangitis (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)
Who cannot join
- 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
Show all 19Show fewer
- 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.
- Serum alpha-fetoprotein (AFP) >20 ng/mL
- INR >1.7
- CP-C cirrhosis
- History or presence of other concomitant liver diseases
Trial locations and contacts
217 sites in 29 countries. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
217 sites in 29 countries
United States54 sites, 54 recruiting
- Recruiting
Piedmont Atlanta Hospital / Piedmont Transplant Institute
Atlanta, Georgia, 30309
- Recruiting
Mercy Medical Center
Baltimore, Maryland, 21202
- Recruiting
Walter Reed National Military
Bethesda, Maryland, 20889
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
Northwestern University
Chicago, Illinois, 60611
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
- Recruiting
University Hosptials Cleveland Medical Center
Cleveland, Ohio, 44106
- Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
- Recruiting
The Ohio State University Medical Center
Columbus, Ohio, 43210
- Recruiting
Gastro One
Cordova, Tennessee, 38018
- Recruiting
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203
- Recruiting
University of Texas Southwestern Medical Center, Professional Office Building One
Dallas, Texas, 75390
- Recruiting
Soma Clinical Trials
Denison, Texas, 75020
- Recruiting
Henry Ford Medical Center - Columbus
Detroit, Michigan, 48202
- Recruiting
MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax
Fairfax, Virginia, 22031
- Recruiting
Covenant Metabolic Specialists, LLC
Fort Myers, Florida, 33912
- Recruiting
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
- Recruiting
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242
- Recruiting
Ochsner Clinic Foundation
Jefferson, Louisiana, 70121
- Recruiting
OM Research LLC
Lancaster, California, 93534
- Recruiting
SCPMG/Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
- Recruiting
Cedar Sinai Medical Center
Los Angeles, California, 90048
- Recruiting
University of Louisville, Clinical Trials Unit
Louisville, Kentucky, 40202
- Recruiting
Northwell Health Center for Liver Disease and Transplantation
Manhasset, New York, 11030
- Recruiting
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, 33136
- Recruiting
Medical College of Wisconsin - 8701 Watertown Plan
Milwaukee, Wisconsin, 53226
- Recruiting
University Health System - East Jefferson General Hospital Campus
New Orleans, Louisiana, 70112
- Recruiting
NYU Langone Health
New York, New York, 10016
- Recruiting
New York-Presbyterian/Weill Cornell Medical Center
New York, New York, 10021
- Recruiting
Mount Sinai
New York, New York, 10029
- Recruiting
Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, 23602
- Recruiting
California Liver Research Institute
Pasadena, California, 91105
- Recruiting
University of Pennsylvania Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
- Recruiting
St. Joseph's Hospital and Medical Center - 350 W. Thomas
Phoenix, Arizona, 85013
- Recruiting
UPMC Center for Liver Diseases
Pittsburgh, Pennsylvania, 15213
- Recruiting
Stanford University
Redwood City, California, 94063
- Recruiting
VCU Health Clinical Research Services Unit (CRSU)
Richmond, Virginia, 23298
- Recruiting
University of Rochester Medical Center - Strong Memorial Hospital
Rochester, Minnesota, 14642
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
Kaiser Roseville
Roseville, California, 95661
- Recruiting
University of California, Davis Medical Center
Sacramento, California, 95817
- Recruiting
American Research Corporation
San Antonio, Texas, 78215
- Recruiting
Pinnacle Clinical Research, PLLC
San Antonio, Texas, 78229
- Recruiting
California Pacific Medical Center - Sutter Pacific Medical Foundation
San Francisco, California, 94109
- Recruiting
Connie Frank Transplant Center at UCSF
San Francisco, California, 94143
- Recruiting
Covenant Metabolic Specialists, LLC
Sarasota, Florida, 33912
- Recruiting
Liver Institute Northwest
Seattle, Washington, 98105
- Recruiting
Kaiser Permanente - South San Francisco Medical Center
South San Francisco, California, 94080
- Recruiting
Florida Research Institute
Tampa, Florida, 34211
- Recruiting
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
China20 sites, 20 recruiting
- Recruiting
Beijing Youan Hospital, Capital Medical University
Beijing, 100000
- Recruiting
Beijing Ditan Hospital, Capital Medical University
Beijing, 100015
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050
- Recruiting
The First Hospital of Jilin University
Changchun, 130021
- Recruiting
West China Hospital of Sichuan University
Chengdu, 610047
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, 401336
- Recruiting
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou
- Recruiting
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, 510630
- Recruiting
Guizhou Provincial People's Hospital
Guiyang, 550002
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, 230032
- Recruiting
The First People's Hospital of Yunnan Province
Kunming, 650032
- Recruiting
The Second Hospital of Nanjing
Nanjing, 210003
- Recruiting
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, 200001
- Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, 830054
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430030
- Recruiting
The First Affiliated Hospital of PLA Air Force Medical University
Xi'an, 710032
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang, 310009
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, 450003
- Recruiting
The Third People's Hospital of Zhenjiang
Zhenjiang, 212021
Argentina10 sites, 10 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, 1181
- Recruiting
Consultorios Médicos Dr. Doreski - PPDS
Buenos Aires, 1426
- Recruiting
Buenos Aires Mácula
Buenos Aires, C1061
- Recruiting
Centro de Investigación y Prevención Cardiovascular
Buenos Aires, C1061
- Recruiting
AES - AS - Glenny Corp. S.A. Buenos Aires
Buenos Aires, C1430
- Recruiting
Higea S.A.
Mendoza, M5500
- Recruiting
DIM Clinica Privada
Ramos Mejía, 1704
- Recruiting
CINME S.A. - Centro de Investigaciones Metabólicas
Recoleta, C1118AAT
- Recruiting
Hospital Provincial Del Centenario
Rosario, 2000
- Recruiting
AES - AS - Clinica Mayo de Urgencias
San Miguel de Tucumán, 4000
Italy10 sites, 10 recruiting
- Recruiting
Azienda Ospedaliero Universitaria delle Marche -Umberto I G.M. Lancisi G. Salesi
Ancona, 60020
- Recruiting
IRCCS Saverio de Bellis-UOSD "Epatopatie"
Castellana Grotte, 70013
- Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
- Recruiting
ASST Santi Paolo Carlo, S.C. Medicina ad Indirizzo Epatologico e Gastroenterologico
Milan, 20142
- Recruiting
Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara
Modena, 41126
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20052
- Recruiting
Azienda Ospedale - Università Padova
Padova, 35100
- Recruiting
A.O.U.P. Paolo Giaccone , U.O.C di Gastroeneterologia
Palermo, 90127
- Recruiting
A.O.U. Pisana, U.O. Epatologia
Pisa, 56124
- Recruiting
Ospedale Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, 71013
South Korea10 sites, 10 recruiting
- Recruiting
Pusan National University Hospital
Busan, 49241
- Recruiting
Kyungpook National University Hospital
Daegu, 41944
- Recruiting
Chonnam National University Hospital
Gwangju, 61455
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Korea University Guro Hospital
Seoul, 08308
- Recruiting
Seoul National University Hospital
Seoul, 3080
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 3722
- Recruiting
Samsung Medical Center
Seoul, 6351
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 6591
Spain10 sites, 10 recruiting
- Recruiting
Complexo Hospitalario Universitario De Santiago
A Coruña, 15706
- Recruiting
Hospital Universitario Fundacion Alcorcon
Alcorcón, 28925
- Recruiting
Hospital Universitario Germans Trias i Pujol
Badalona, 08916
- Recruiting
Hospital del Mar
Barcelona, 08003
- Recruiting
Hospital Universitario Vall d'Hebron-VIHR
Barcelona, 08035
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
C.H. Regional Reina Sofia - PPDS
Córdoba, 14004
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander, 39008
- Recruiting
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41010
Turkey (Türkiye)10 sites, 10 recruiting
- Recruiting
Adana City Training and Research Hospital
Adana, 1370
- Recruiting
Ankara Bilkent City Hospital
Ankara, 06800
- Recruiting
Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital
Gaziantep, 27630
- Recruiting
Uludag University Medical Faculty
Görükle, 16059
- Recruiting
Ege University
Izmir, 35040
- Recruiting
Katip Celebi University
Karabağlar, 35150
- Recruiting
Kocaeli University Medical Faculty Hospital
Kocaeli, 41380
- Recruiting
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, 33110
- Recruiting
Marmara University Pendik Training and Research Hospital
Pendik, 34899
- Recruiting
Rize Recep Tayyip Erdogan University Training and Research Hospital
Rize Merkez, 53020
United Kingdom10 sites, 10 recruiting
- Recruiting
Hull Royal Infirmary
Hull, HU32JZ
- Recruiting
East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital
Ipswich, IP4 5PD
- Recruiting
St James's University Hospital - PPDS
Leeds, LS9 7TF
- Recruiting
The Royal London Hospital
London, E1 1BB
- Recruiting
Royal Free Hospital
London, NW2 2QG
- Recruiting
King's College Hospital
London, SE5 9RS
- Recruiting
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
- Recruiting
John Radcliffe Hospital
Oxford, OX3 9DU
- Recruiting
Sheffield teaching hospital NHS foundation trust
Sheffield, S10 2JF
- Recruiting
New Cross Hospital
Wolverhampton, WV10 0QP
France9 sites, 9 recruiting
- Recruiting
AP-HP - Hopital Avicenne
Bobigny, 93000
- Recruiting
Hôpital Claude Huriez-Lille-1 Place de Verdun
Lille, 59000
- Recruiting
Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
Lyon, 69317
- Recruiting
CHU-Montpellier-Hopital St Eloi
Montipellier, 34295
- Recruiting
Hopital Saint Antoine, Assistance Publique-Hopitaux de Paris
Paris, 75012
- Recruiting
AP-HP Hopital Henri Mondor
Paris, 94000
- Recruiting
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, 67000
- Recruiting
CHRU de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54500
- Recruiting
AP-HP - Hôpital Paul Brousse
Villejuif, 94804
Canada7 sites, 7 recruiting
- Recruiting
University of Calgary
Calgary, T2N 4Z6
- Recruiting
University of Alberta
Edmonton, T6G 2B7
- Recruiting
Centre Hospitalier de l'Universite de Montreal
Montreal, H2L 4M1
- Recruiting
Ottawa Hospital
Ottawa, K1H 8L6
- Recruiting
Diex Recherche - Québec - PPDS
Québec, G1V 4T3
- Recruiting
Toronto General Hospital
Toronto, M5G 2C4
- Recruiting
GI Research Institute Foundation
Vancouver, V6G 2Z6
Israel7 sites, 7 recruiting
- Recruiting
Soroka University Medical Centre
Beersheba, 84101
- Recruiting
Lady Davis Carmel Medical Center
Haifa, 33394
- Recruiting
Liver Unit, institute of Gasteroenterology and Liver Diseases
Jerusalem, 91120
- Recruiting
Rabin Medical Center - PPDS
Petah Tikva, 49100
- Recruiting
Rambam Health Care Campus - PPDS
Ramat Gan, 52394
- Recruiting
The Chaim Sheba Medical Center - PPDS
Ramat Gan, 5266202
- Recruiting
Tel Aviv Sourasky Medical Center Ichilov
Tel Aviv, 64239
Taiwan7 sites, 7 recruiting
- Recruiting
Chiayi Christian Hospital
Chiayi City
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City, 80756
- Recruiting
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
- Recruiting
National Cheng Kung University Hospital
Tainan, 70403
- Recruiting
National Taiwan University Hospital
Taipei, 10002
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
- Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan, 33305
Mexico6 sites, 6 recruiting
- Recruiting
Clinica de Higado y Gastroenterologia Integral, S.C.
Cuernavaca, 62170
- Recruiting
PROACTIVE CR MEXICO SA de CV
Irapuato, 36650
- Recruiting
Centro De Investigacion Y Gastroenterogia, S.C.
México, 76806
- Recruiting
Consultorio Medico - Distrito Federal
Mexico City, 6700
- Recruiting
Oaxaca Site Management Organization - Hospital - OSMO - PPDS
Oaxaca City, 71256
- Recruiting
FAICIC
Veracruz, 91900
Australia5 sites, 5 recruiting
- Recruiting
Flinders Medical Center
Adelaide, South Australia, 5042
- Recruiting
Monash Health, Monash Medical Centre
Clayton, Victoria, 3168
- Recruiting
Northern Health
Epping, Victoria, 3076
- Recruiting
Alfred Hospital
Melbourne, Victoria, 3004
- Recruiting
Princess Alexandra Hospital
Queensland, Queensland, 4102
Portugal5 sites, 5 recruiting
- Recruiting
Centro Clínico Académico, Braga - Hospital de Braga
Braga, 4710-243
- Recruiting
ULS do Alto Ave, EPE - Hospital da Senhora da Oliveira Guimarães
Creixomil
- Recruiting
Hospital da Luz Lisboa
Lisbon, 1500-650
- Recruiting
ULS de Santo António, EPE - Hospital de Santo António
Porto, 4099-001
- Recruiting
ULS de Matosinhos, EPE - Hospital Pedro Hispano
Porto, 4464-513
Austria4 sites, 4 recruiting
- Recruiting
Landeskrankenhaus Hall
Hall in Tirol, 6060
- Recruiting
Krankenhaus der Barmherzigen Brüder
Vienna, 1020
- Recruiting
Medizinische Universität Wien
Vienna, 1090
- Recruiting
Klinikum Wels-Grieskirchen GmbH - Standort Wels
Wels, 4600
Chile4 sites, 4 recruiting
- Recruiting
Centro de Investigación y Prevención Cardiovascular
La Serena, 1720506
- Recruiting
Pontificia Universidad Católica de Chile
Santiago, 8320000
- Recruiting
BIOCINETIC Ltda
Santiago, 8330336
- Recruiting
Clinical Research Chile SpA - PPDS
Valdivia, 5110683
Germany4 sites, 4 recruiting
- Recruiting
Universitätsklinikum Regensburg
Bayern, 93042
- Recruiting
Charité Campus Virchow-Klinikum-Augustenburger Platz 1
Berlin, 13353
- Recruiting
Universitatsklinikum des Saarlandes
Homburg, 66421
- Recruiting
Gastroenterologisch - Hepatologisches MVZ Kiel GmbH
Kiel, 24146
Singapore4 sites, 4 recruiting
- Recruiting
National University Hospital
Singapore, 119228
- Recruiting
Singapore General Hospital (SGH)
Singapore, 169608
- Recruiting
Tan Tock Seng Hospital
Singapore, 169608
- Recruiting
Changi General Hospital
Singapore, 529889
Belgium3 sites, 3 recruiting
- Recruiting
UZ Antwerpen
Edegem, 2650
- Recruiting
UZ Gent
Ghent, 9000
- Recruiting
UZ Leuven - PPDS
Leuven, 3000
Czechia3 sites, 3 recruiting
- Recruiting
Fakultni nemocnice Ostrava
Ostrava, 70852
- Recruiting
RESEARCH Site s.r.o
Pilsen, 301 00
- Recruiting
Vseobecná fakultni nemocnice v Praze Nemocnicni lekarna odd. HVLP - Klinicke hodnoceni leciv
Prague, 128 08
Greece3 sites, 3 recruiting
- Recruiting
Evangelismos General Hospital
Athens, 106 76
- Recruiting
University General Hospital of Larissa
Larissa, 41 110
- Recruiting
General Hospital of Thessaloniki ''Hippokratio''
Thessaloniki, 546 41
Hong Kong3 sites, 3 recruiting
- Recruiting
Prince of Wales Hospital - Hong Kong
Hong Kong, 000
- Recruiting
Queen Mary Hospital - PPDS
Hong Kong, 999077
- Recruiting
Princess Margaret Hospital - Hong Kong
Hong Kong
Hungary2 sites, 2 recruiting
- Recruiting
Semmelweis Egyetem - Sebészeti,
Budapest, 1082
- Recruiting
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400
Poland2 sites, 2 recruiting
- Recruiting
ID Clinic Arkadiusz Pisula
Mysłowice, 41-400
- Recruiting
PlanetMed SP. z. o. o
Wroclaw, 52-210
Switzerland2 sites, 2 recruiting
- Recruiting
Universitätsspital Bern
Bern, 3010
- Recruiting
Universitätsspital Zürich
Zurich, 8091
Denmark1 site, 1 recruiting
- Recruiting
Aarhus Universitetshospital
Aarhus, 8200
Puerto Rico1 site, 1 recruiting
- Recruiting
Galenus Group - Puerto Rico
Manati, 00674
Romania1 site, 1 recruiting
- Recruiting
Institutul Clinic Fundeni
Bucharest, 022328
About this study
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
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.
- Conditions
- Primary Biliary Cholangitis
- Being tested
- Seladelpar, Placebo
- Keywords
- Primary Biliary Cholangitis (PBC), PBC
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeladelparDrug
Also called Livdelzi®
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Seladelpar | Experimental | Participants with Child-Pugh (CP)-A cirrhosis will receive seladelpar 10 mg orally once daily or participants with CP-B cirrhosis will receive seladelpar 5 mg orally once daily, for up to 36 months. Receives: Drug: Seladelpar |
| Placebo | Placebo comparator | Participants with CP-A or CP-B will be randomized to received placebo to match one capsule daily for up to 36 months. Receives: Drug: Placebo |
| Open Label Extension Phase | Experimental | Participants with CP-A who remained on the study drug at week 156 will receive seladelpar 10 mg daily or participants with CP-B will received seladelpar 5 mg daily for a maximum of 3 years. Receives: Drug: Seladelpar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival (EFS)
EFS is defined 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
Measured: 36 months
Secondary outcomes (5)
Overall Survival (OS)
Time from start of treatment to death from any cause.
Measured: 36 months
Liver Transplant-Free Survival (LTFS)
Time from start of treatment to the first occurrence of liver-related death or liver transplantation.
Measured: 36 months
Time to Hospitalization
Time from start of treatment to the first occurrence of hospitalization for qualifying Primary biliary cholangitis (PBC) clinical events
Measured: 36 months
Time to Each Type of Adjudicated PBC Clinical Event: Model for End-Stage Liver Disease (MELD) score ≥ 15
Measured: 36 months
Time to Each Type of Adjudicated PBC Clinical Event: Ascites Requiring Treatment
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start7 Sep 2023
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051617
- Sponsor's protocol ID
- CB8025-41837
- Other IDs
- 2024-516525-31-00
- Acronym
- AFFIRM
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2023
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No