Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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.
More Gilead Sciences trials in Italy
Other trials for the same condition
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 Italy