Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)
Public ClinicalTrials.gov record NCT03301506. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
Study identification
- NCT ID
- NCT03301506
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Gilead Sciences
- Industry
- Enrollment
- 340 participants
Conditions and interventions
Conditions
Interventions
- Seladelpar 10 mg Capsule Drug
- Seladelpar 5 mg Capsule Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 11, 2017
- Primary completion
- Oct 31, 2028
- Completion
- Nov 30, 2028
- Last update posted
- May 3, 2026
2017 – 2028
United States locations
- U.S. sites
- 40
- U.S. states
- 21
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Diagnostic Center | Little Rock | Arkansas | 72205 | — |
| Stanford University School of Medicine | Palo Alto | California | 94305 | — |
| California Liver Research Institute | Pasadena | California | 91105 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| University of Colorado - Denver - PPDS | Aurora | Colorado | 80045 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | — |
| Covenant Research Fort Myers | Fort Myers | Florida | 33606 | — |
| Florida Digestive Health Specialist | Lakewood Rch | Florida | 34211 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | — |
| Covenant Research, LLC | Sarasota | Florida | 33912 | — |
| Digestive Healthcare of Georgia PC | Atlanta | Georgia | 30309 | — |
| University of Chicago Hospitals | Chicago | Illinois | 60637 | — |
| East Jefferson General Hospital | New Orleans | Louisiana | 70112 | — |
| Mercy Medical Center (Baltimore) | Baltimore | Maryland | 21202 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center - 330 Brookline Ave | Boston | Massachusetts | 02215 | — |
| Henry Ford Health System | Novi | Michigan | 48377 | — |
| MNGI Digestive Health PA-Plymouth | Minneapolis | Minnesota | 55413 | — |
| Southern Therapy and Advanced Research LLC | Jackson | Mississippi | 39157 | — |
| Saint Louis University | St Louis | Missouri | 63104 | — |
| NYU Langone Medical Center | New York | New York | 10021 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| University of Rochester Medical Center - PPDS | Rochester | New York | 14642 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Northeast Clinical Research Center, LLC | Bethlehem | Pennsylvania | 18017 | — |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Galen Medical Group | Chattanooga | Tennessee | 37404 | — |
| Gastro One-8110 Walnut Run Rd | Cordova | Tennessee | 38018 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 39090 | — |
| Liver Institute at Methodist Dallas | Dallas | Texas | 75203 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| The Texas Liver Institute - 607 Camden St | San Antonio | Texas | 78215 1619 | — |
| Pinnacle Clinical Research, PLLC | San Antonio | Texas | 78229 | — |
| Maryview Hospital Inc., d/b/a Bon Secours Liver Institute of Hampton Roads | Newport News | Virginia | 23602 | — |
| Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond | Richmond | Virginia | 23226 | — |
| Liver Institute Northwest, PLLC | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 69 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03301506, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 3, 2026 · Synced May 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03301506 live on ClinicalTrials.gov.