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

Last updated: April 29, 2025
Sponsor: Gilead Sciences
Overall Status: Active - Recruiting

Phase

3

Condition

Liver Disorders

Liver Disease

Primary Biliary Cholangitis

Treatment

Seladelpar 10 mg

Placebo

Seladelpar

Clinical Study ID

NCT06051617
CB8025-41837
2024-516525-31
2024-516525-31-00
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

Individuals must meet the following criteria to be eligible for study participation:

  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 asecond effective birth control method during the study and for at least 90 daysafter the last dose. Male individuals who are sexually active with female partnersof reproductive potential must use barrier contraception, and their female partnersmust 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 drugadministration and be able to complete the study schedule of assessments (SOA)

Exclusion

Exclusion Criteria:

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

  1. Prior exposure to seladelpar

  2. A medical condition other than PBC that, in the Investigator's opinion, wouldpreclude full participation in the study

  3. History of liver transplantation or actively listed for cadaveric or planned livingdonor transplant.

  4. Decompensated cirrhosis

  5. Evidence of portal vein thrombosis based on imaging at time of Screening by Dopplerultrasound or prior evidence by CT or MRI

  6. Hospitalization for liver-related complication within 12 weeks of Screening

  7. Laboratory parameters at Screening:

  8. Alkaline phosphatase (ALP) < 1.5× Upper limit of normal (ULN) or ≥ 10×ULN

  9. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN

  10. Total bilirubin (TB) ≥5×ULN

  11. Platelet count ≤50×10^3/µL

  12. Albumin ≤2.8 g/dL

  13. Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m^2

  14. MELD score >12. For individuals on anticoagulation medication, baselineInternational normalized ratio (INR) determination for MELD score calculationshould take anticoagulant use into account, in consultation with the MedicalMonitor.

  15. Serum alpha-fetoprotein (AFP) >20 ng/mL

  16. INR >1.7

  17. CP-C cirrhosis

  18. History or presence of other concomitant liver diseases

Study Design

Total Participants: 318
Treatment Group(s): 3
Primary Treatment: Seladelpar 10 mg
Phase: 3
Study Start date:
September 07, 2023
Estimated Completion Date:
August 31, 2030

Study Description

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

Connect with a study center

  • Flinders Medical Center

    Adelaide, South Australia 5042
    Australia

    Active - Recruiting

  • Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • GI Research Institute Foundation

    Vancouver, V6G 2Z6
    Canada

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Hospital

    Daegu, 41944
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, 13620
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 3722
    Korea, Republic of

    Active - Recruiting

  • Adana City Hospital

    Yüreğir, Adana 1370
    Turkey

    Site Not Available

  • Katip Celebi University

    İzmir, Karabaglar 35150
    Turkey

    Site Not Available

  • Adana City Training and Research Hospital

    Adana, 1370
    Turkey

    Active - Recruiting

  • Ankara Bilkent City Hospital

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Ege University

    Bornova, 35100
    Turkey

    Site Not Available

  • Uludag University Medical Faculty Gorkule Kampusu

    Bursa, 16059
    Turkey

    Site Not Available

  • Ankara Bilkent City Hospital

    Cankaya, 06800
    Turkey

    Site Not Available

  • Gaziantep University Medical Faculty Sahinbey Research and Practice Hospital

    Gaziantep, 27630
    Turkey

    Active - Recruiting

  • Uludag University Medical Faculty

    Gorukle, 16059
    Turkey

    Active - Recruiting

  • Marmara University Pendik Training and Research Hospital

    Istanbul, 34899
    Turkey

    Site Not Available

  • Ege University

    Izmir, 35040
    Turkey

    Active - Recruiting

  • Katip Celebi University

    Karabağlar, 35150
    Turkey

    Active - Recruiting

  • Kocaeli University Medical Faculty Hospital

    Kocaeli, 41380
    Turkey

    Active - Recruiting

  • Rize Recep Tayyip Erdogan University Training and Research Hospital

    Maltepe, 34840
    Turkey

    Site Not Available

  • Mersin Universitesi Tip Fakultesi Hastanesi

    Mersin, 33110
    Turkey

    Active - Recruiting

  • Marmara University Pendik Training and Research Hospital

    Pendik, 34899
    Turkey

    Active - Recruiting

  • Rize Recep Tayyip Erdogan University Training and Research Hospital

    Rize, 53020
    Turkey

    Site Not Available

  • Rize Recep Tayyip Erdogan University Training and Research Hospital

    Rize Merkez, 53020
    Turkey

    Active - Recruiting

  • Ege University, Department of Gastroenterology

    İzmir, 35100
    Turkey

    Active - Recruiting

  • OM Research LLC

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Cedar Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • SCPMG/ Kaise Permanente Los Angeles Medical Center

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • SCPMG/Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • California Liver Research Center

    Pasadena, California 91105
    United States

    Active - Recruiting

  • California Liver Research Institute

    Pasadena, California 91105
    United States

    Active - Recruiting

  • University of California, Davis Medical Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • University of California, Davis Medical Center (Study Visits)

    Sacramento, California 95817
    United States

    Active - Recruiting

  • California Pacific Medical Center - Sutter Pacific Medical Foundation

    San Francisco, California 94109
    United States

    Active - Recruiting

  • Connie Frank Transplant Center at UCSF

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Covenant Metabolic Specialists, LLC

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Florida Research Institute

    Lakewood Ranch, Florida 34211
    United States

    Site Not Available

  • Florida Research Institute, LLC

    Lakewood Ranch, Florida 34211
    United States

    Active - Recruiting

  • Schiff Center for Liver Diseases/University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Miami Hospital

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Covenant Metabolic Specialists, LLC

    Sarasota, Florida 33912
    United States

    Active - Recruiting

  • Florida Research Institute

    Tampa, Florida 34211
    United States

    Active - Recruiting

  • Piedmont Atlanta Hospital / Piedmont Transplant Institute

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • Piedmont Atlanta Hospital/Piedmont Transplant Institute

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • University Of Iowa Hospitals And Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • University of Louisville, Clinical Trials Unit

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Ochsner Clinic Foundation

    Jefferson, Louisiana 70121
    United States

    Active - Recruiting

  • University Healthcare System East Jefferson General Hospital Campus

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Active - Recruiting

  • University Health System - East Jefferson General Hospital Campus

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • Mercy Medical Center

    Baltimore, Maryland 21202
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Beth Israel Deconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Henry Ford Medical Center - Columbus

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Henry Ford Medical Center

    Novi, Michigan 48377
    United States

    Site Not Available

  • MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax

    Plymouth, Minnesota 55446
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    Jefferson City, Missouri 70121
    United States

    Site Not Available

  • Northwell Health Center for Liver Disease and Transplantation

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • University Hosptials Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • UPMC Center for Liver Diseases

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Gastro One

    Cordova, Tennessee 38018
    United States

    Active - Recruiting

  • Gastro One

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas 75203
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center, Professional Office Building One

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Pinnacle Clinical Research, LLC

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Pinnacle Clinical Research, PLLC

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • MedStar Health Research Institute / MedStar Georgetown Transplant Institute at Fairfax

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Medstar Health Research Institute/MedStar Georgetown Transplant

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads

    Newport News, Virginia 23602
    United States

    Active - Recruiting

  • Mayview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads

    Newport News, Virginia 23602
    United States

    Site Not Available

  • Maryview Hospital LLC d/b/a Bon Secours Liver Institute of Hampton Roads

    Richmond, Virginia 23226
    United States

    Site Not Available

  • VCU Health Clinical Research Services Unit (CRSU)

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Liver Institute Northwest

    Seattle, Washington 98105
    United States

    Active - Recruiting

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