🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT03301506
Active, not recruiting Phase 3

Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)

NCT03301506 · tracked via the Priya Life Science UK tracker
Sponsor
Gilead Sciences
Phase
Phase 3
Started
2017-12-12
Last updated
2026-05-04

Condition(s) studied

Primary Biliary Cirrhosis

Investigational drug(s) / intervention(s)

Seladelpar 5 mg CapsuleSeladelpar 10 mg Capsule

Seladelpar 5 mg Capsule: Participants will be assigned to a treatment group if tolerability issues noted in the previous study.

Seladelpar 10 mg Capsule: Participants will be assigned to a treatment group unless there are tolerability issues.

Study summary

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Must have given written informed consent (signed and dated) 2. Participated in a PBC study with seladelpar 3. Females of reproductive potential must use at least one 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 Exclusion Criteria: Exclusion criteria are only applicable for individuals with a seladelpar interruption greater than 4 weeks prior to Day 1 of this study and for individuals who participated in CB8025-21838 irrespective of seladelpar interruption. 1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar 2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results (eg, cancer, any active infection) 3. AST or ALT above 3 × the upper limit of normal (ULN) 4. Total bilirubin above 2 × ULN 5. MELD score ≥ 12. For individuals on anticoagulation medication, evaluation of the baseline INR, in concert with any current dose adjustments in anti-coagulant medications, will be taken into account when calculating this score. This will be done in consultation with the medical monitor. 6. Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the lower limit of normal (LLN) AND total bilirubin above 1 × ULN) 7. eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula) 8. Auto-immune hepatitis 9. Primary sclerosing cholangitis 10. Known history of alpha-1-antitrypsin deficiency 11. Known history of chronic viral hepatitis 12. For females, pregnancy or breast-feeding 13. Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids (eg prednisone, prednisolone, budesonide) (\>2 weeks) within 2 months prior to Screening 14. Current use of fibrates or use of fibrates within 3 months prior to Screening 15. Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening 16. Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening 17. History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening 18. Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening 19. Any other condition(s) that would compromise the safety of the individual or compromise the quality of the clinical study, as judged by the Investigator 20. Immunosuppressant therapies (eg, cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics) 21. Other medications that effect liver or GI functions such as absorption of medications or the roux-en-y gastric bypass procedure may be prohibited and should be discussed with the medical monitor on a case-by-case basis 22. Positive for: 1. Hepatitis B, defined as the presence of hepatitis B surface antigen 2. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA) 3. Human immunodeficiency virus (HIV) antibody 23. Active COVID-19 infection during screening Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (109)

FacilityCityRegionStatus
Arkansas Diagnostic Center Little Rock Arkansas
Stanford University School of Medicine Palo Alto California
California Liver Research Institute Pasadena California
University of California Davis Medical Center Sacramento California
California Pacific Medical Center San Francisco California
University of Colorado - Denver - PPDS Aurora Colorado
Yale University School of Medicine New Haven Connecticut
Covenant Research Fort Myers Fort Myers Florida
Florida Digestive Health Specialist Lakewood Rch Florida
University of Miami Miller School of Medicine Miami Florida
Covenant Research, LLC Sarasota Florida
Digestive Healthcare of Georgia PC Atlanta Georgia
University of Chicago Hospitals Chicago Illinois
East Jefferson General Hospital New Orleans Louisiana
Mercy Medical Center (Baltimore) Baltimore Maryland
Massachusetts General Hospital Boston Massachusetts
Beth Israel Deaconess Medical Center - 330 Brookline Ave Boston Massachusetts
Henry Ford Health System Novi Michigan
MNGI Digestive Health PA-Plymouth Minneapolis Minnesota
Southern Therapy and Advanced Research LLC Jackson Mississippi
Saint Louis University St Louis Missouri
NYU Langone Medical Center New York New York
Weill Cornell Medical College New York New York
Icahn School of Medicine at Mount Sinai New York New York
University of Rochester Medical Center - PPDS Rochester New York
Duke University Medical Center Durham North Carolina
Northeast Clinical Research Center, LLC Bethlehem Pennsylvania
Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Galen Medical Group Chattanooga Tennessee
Gastro One-8110 Walnut Run Rd Cordova Tennessee
Vanderbilt University Medical Center Nashville Tennessee
University of Texas Southwestern Medical Center Dallas Texas
Liver Institute at Methodist Dallas Dallas Texas
Baylor College of Medicine Houston Texas
The Texas Liver Institute - 607 Camden St San Antonio Texas
Pinnacle Clinical Research, PLLC San Antonio Texas
Maryview Hospital Inc., d/b/a Bon Secours Liver Institute of Hampton Roads Newport News Virginia
Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond Richmond Virginia
Liver Institute Northwest, PLLC Seattle Washington

+ 69 more sites — see the full list on the official registry below.

More Gilead Sciences trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03301506 on ClinicalTrials.gov ↗ ← All trials in the UK