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

Running, not enrolling · Phase 3

Conditions studied: Primary Biliary Cirrhosis

In brief

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

Key facts

Study ID: NCT03301506
Run by: Gilead Sciences
People needed: 340
Starts: 2017-12-12
Expected to finish: 2028-12-01
Last updated by the study team: 2026-05-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Must have given written informed consent (signed and dated)
Participated in a PBC study with seladelpar
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

You may not qualify if…

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.
Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
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)
AST or ALT above 3 × the upper limit of normal (ULN)
Total bilirubin above 2 × ULN
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.
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)
eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)
Auto-immune hepatitis
Primary sclerosing cholangitis
Known history of alpha-1-antitrypsin deficiency
Known history of chronic viral hepatitis
For females, pregnancy or breast-feeding
Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids (eg prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to Screening
Current use of fibrates or use of fibrates within 3 months prior to Screening
Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening
Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening
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
Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening
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
Immunosuppressant therapies (eg, cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics)
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
Positive for:
Hepatitis B, defined as the presence of hepatitis B surface antigen
Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA)

Where it is running

Stanford University School of Medicine — Palo Alto, 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 — San Francisco, California, United States
University of Colorado - Denver - PPDS — Aurora, Colorado, United States
Yale University School of Medicine — New Haven, Connecticut, United States
Covenant Research Fort Myers — Fort Myers, Florida, United States
Florida Digestive Health Specialist — Lakewood Rch, Florida, United States
University of Miami Miller School of Medicine — Miami, Florida, United States
Covenant Research, LLC — Sarasota, Florida, United States
Digestive Healthcare of Georgia PC — Atlanta, Georgia, United States
University of Chicago Hospitals — Chicago, Illinois, United States
East Jefferson General Hospital — New Orleans, Louisiana, United States
Mercy Medical Center (Baltimore) — Baltimore, Maryland, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center - 330 Brookline Ave — Boston, Massachusetts, United States
Henry Ford Health System — Novi, Michigan, United States
MNGI Digestive Health PA-Plymouth — Minneapolis, Minnesota, United States
Southern Therapy and Advanced Research LLC — Jackson, Mississippi, United States
Saint Louis University — St Louis, Missouri, United States
NYU Langone Medical Center — New York, New York, United States
Weill Cornell Medical College — New York, New York, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
University of Rochester Medical Center - PPDS — Rochester, New York, United States
Arkansas Diagnostic Center — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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