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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT03301506

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.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 6:12 PM EDT

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

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 12, 2017 (Actual)
Primary completion
Nov 2028 (Estimated)
Completion
Dec 2028 (Estimated)
Last update posted
May 4, 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 4, 2026 · Synced Oct 20, 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 public registry record, listed eligibility criteria, and available contact information for NCT03301506 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →