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NCT06051617 · ClinicalTrials.gov registry record · Phase 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
A Phase 3 study of Primary Biliary Cholangitis, sponsored by Gilead Sciences.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 318
- Enrollment target
- 20
- Study locations
NCT06051617: Recruiting Phase 3 study of Primary Biliary Cholangitis, sponsored by Gilead Sciences.
NCT06051617 is a Phase 3 study of Primary Biliary Cholangitis that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 318 participants, above the 167-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (90% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06051617, a Phase 3 study of Primary Biliary Cholangitis, is actively recruiting participants, sponsored by Gilead Sciences.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 318 participants
- Enrollment target
- 20
- Study locations
Study Summary
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Primary Outcome
EFS as measured by the time from start of treatment to the first occurrence of any of the following clinical events: 1. Death by any cause; 2. Liver transplantation; 3. MELD score ≥15; 4. Ascites requiring treatment; 5. Hospitalization for any of the following: 1. Esophageal or gastric variceal bleeding 2. Hepatic encephalopathy 3. Spontaneous bacterial peritonitis
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Seladelpar
Study Locations (20)
California
- OM Research LLC - Lancaster
- SCPMG/Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Cedar Sinai Medical Center - Los Angeles
- California Liver Research Institute - Pasadena
- Stanford University - Redwood City
- University of California, Davis Medical Center - Sacramento
- California Pacific Medical Center - Sutter Pacific Medical Foundation - San Francisco
- Connie Frank Transplant Center at UCSF - San Francisco
Florida
- Covenant Metabolic Specialists, LLC - Fort Myers
- Schiff Center for Liver Diseases/University of Miami - Miami
- Covenant Metabolic Specialists, LLC - Sarasota
- Florida Research Institute - Tampa
Illinois
- Northwestern University - Chicago
- University of Chicago Medical Center - Chicago
Louisiana
- Ochsner Clinic Foundation - Jefferson
- University Health System - East Jefferson General Hospital Campus - New Orleans
Arizona
- St. Joseph's Hospital and Medical Center - 350 W. Thomas - Phoenix
Georgia
- Piedmont Atlanta Hospital / Piedmont Transplant Institute - Atlanta
Iowa
- University Of Iowa Hospitals And Clinics - Iowa City
Kentucky
- University of Louisville, Clinical Trials Unit - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2023-09-07 |
| Est. Completion | 2030-08 |
| Phase | Phase 3 |
What NCT06051617 shows while recruiting
NCT06051617 is an interventional study that assigns participants to a tested intervention. The registered 318 participants enrollment target is mid-sized for trials with a published cap, above the 167-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (90% higher).
The record links to 1 condition, with Primary Biliary Cholangitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06051617 names 20 study sites across 8 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT06051617 about?
NCT06051617 is a clinical study titled "Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis". To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
What is the current status of trial NCT06051617?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 318 participants. The study started on 2023-09-07. Estimated completion is 2030-08.
What conditions does trial NCT06051617 study?
This clinical trial studies the following conditions: Primary Biliary Cholangitis.
What interventions are being tested in trial NCT06051617?
The interventions under investigation include: Placebo (DRUG), Seladelpar (DRUG).
Who is sponsoring clinical trial NCT06051617?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06051617 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Biliary Cholangitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06051617's enrollment target sits among peer trials
318 2nd of 8 the highest of 8 other Primary Biliary Cholangitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Biliary Cholangitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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