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)
Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results — Through study completion, up to 60 Months
Trial sites (109)
Facility
City
Region
Status
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.
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.
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