Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
NCT ID: NCT06051617
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
318 participants
INTERVENTIONAL
2023-09-07
2030-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Seladelpar
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
Placebo
One capsule daily for up to 36 months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Must be at least 18 years old.
2. Must have a confirmed prior diagnosis of PBC
3. Evidence of cirrhosis
4. CP Score A or B
5. 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
6. 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
1. Prior exposure to seladelpar
2. A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study
3. History of liver transplantation or actively listed for cadaveric or planned living donor transplant.
4. Decompensated cirrhosis
5. Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
6. Hospitalization for liver-related complication within 12 weeks of Screening
7. 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) ≥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
8. CP-C cirrhosis
9. History or presence of other concomitant liver diseases
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
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
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
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
UPMC Center for Liver Diseases
Pittsburgh, Pennsylvania, 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
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
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
University of Calgary
Calgary, , Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, , Canada
Ottawa Hospital
Ottawa, , Canada
Diex Recherche - Québec - PPDS
Québec, , 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
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
Charité Campus Virchow-Klinikum-Augustenburger Platz 1
Berlin, , Germany
Evangelismos General Hospital
Athens, , Greece
University General Hospital of Larissa
Larissa, , Greece
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
IRCCS Saverio de Bellis-UOSD "Epatopatie"
Castellana Grotte, , 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
A.O.U.P. Paolo Giaccone , U.O.C di Gastroeneterologia
Palermo, , Italy
A.O.U. Pisana, U.O. Epatologia
Pisa, , Italy
Clinica de Higado y Gastroenterologia Integral, S.C.
Cuernavaca, , 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
ID Clinic Arkadiusz Pisula
Mysłowice, , Poland
PlanetMed SP. z. o. o
Wroclaw, , Poland
Institutul Clinic Fundeni
Bucharest, , Romania
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
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
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
Universitätsspital Bern
Bern, , Switzerland
Universitätsspital Zürich
Zurich, , Switzerland
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)
East Suffolk and North Essex NHS Foundation Trust, Ipswich Hospital
Ipswich, , United Kingdom
The Royal London Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Gilead Clinical Study Information Center
Role: CONTACT
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Related Links
Access external resources that provide additional context or updates about the study.
Gilead Clinical Trials Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-516525-31-00
Identifier Type: OTHER
Identifier Source: secondary_id
CB8025-41837
Identifier Type: -
Identifier Source: org_study_id