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NCT03301506 · ClinicalTrials.gov registry record · Phase 3
Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)
A Phase 3 study of Primary Biliary Cirrhosis, sponsored by Gilead Sciences.
- Active
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT03301506: Active Phase 3 study of Primary Biliary Cirrhosis, sponsored by Gilead Sciences.
NCT03301506 is a Phase 3 study of Primary Biliary Cirrhosis that is active but no longer recruiting, run by Gilead Sciences. The registered enrollment target is 500 participants, below the 1,371-participant average among 7 other Primary Biliary Cirrhosis trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03301506, a Phase 3 study of Primary Biliary Cirrhosis, is active but no longer recruiting, sponsored by Gilead Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study Summary
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
Conditions Studied
Interventions
- DRUG Seladelpar 5 mg Capsule
- DRUG Seladelpar 10 mg Capsule
Study Locations (20)
California
- Stanford University School of Medicine - Palo Alto
- California Liver Research Institute - Pasadena
- University of California Davis Medical Center - Sacramento
- California Pacific Medical Center - San Francisco
Florida
- Covenant Research Fort Myers - Fort Myers
- Florida Digestive Health Specialist - Lakewood Rch
- University of Miami Miller School of Medicine - Miami
- Covenant Research, LLC - Sarasota
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - 330 Brookline Ave - Boston
Arkansas
- Arkansas Diagnostic Center - Little Rock
Colorado
- University of Colorado - Denver - PPDS - Aurora
Connecticut
- Yale University School of Medicine - New Haven
Georgia
- Digestive Healthcare of Georgia PC - Atlanta
Illinois
- University of Chicago Hospitals - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2017-12-12 |
| Est. Completion | 2028-11 |
| Phase | Phase 3 |
What the registry record for NCT03301506 still lists
NCT03301506 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 1,371-participant average among 7 other Primary Biliary Cirrhosis trials with a reported enrollment target (64% lower).
The record links to 1 condition, with Primary Biliary Cirrhosis appearing as the primary indexed condition, and to 2 interventions - of which Seladelpar 5 mg Capsule is the first listed.
NCT03301506 names 20 study sites across 13 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03301506 about?
NCT03301506 is a clinical study titled "Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)". An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
What is the current status of trial NCT03301506?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2017-12-12. Estimated completion is 2028-11.
What conditions does trial NCT03301506 study?
This clinical trial studies the following conditions: Primary Biliary Cirrhosis.
What interventions are being tested in trial NCT03301506?
The interventions under investigation include: Seladelpar 5 mg Capsule (DRUG), Seladelpar 10 mg Capsule (DRUG).
Who is sponsoring clinical trial NCT03301506?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03301506 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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