Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Condition(s) studied
Investigational drug(s) / intervention(s)
Seladelpar: Administered orally
Placebo: Administered orally
Study summary
The goal of this clinical study is to learn more about the study drug, seladelpar, and its effects on clinical outcomes in participants with primary biliary cholangitis (PBC) and compensated cirrhosis.
The primary objective of this study is to evaluate the effect of seladelpar compared to placebo on EFS. EFS is defined as the time from start of treatment to the first occurrence of any of the following adjudicated events up to Week 156.
Eligibility
Primary outcome measure(s)
- Event Free Survival (EFS) — 36 months
EFS is defined 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
Trial sites (217)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| St. Joseph's Hospital and Medical Center - 350 W. Thomas | Phoenix | Arizona | Recruiting |
| OM Research LLC | Lancaster | California | Recruiting |
| SCPMG/Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | Recruiting |
| Cedar Sinai Medical Center | Los Angeles | California | Recruiting |
| California Liver Research Institute | Pasadena | California | Recruiting |
| Stanford University | Redwood City | California | Recruiting |
| Kaiser Roseville | Roseville | California | Recruiting |
| University of California, Davis Medical Center | Sacramento | California | Recruiting |
| California Pacific Medical Center - Sutter Pacific Medical Foundation | San Francisco | California | Recruiting |
| Connie Frank Transplant Center at UCSF | San Francisco | California | Recruiting |
| Kaiser Permanente - South San Francisco Medical Center | South San Francisco | California | Recruiting |
| Covenant Metabolic Specialists, LLC | Fort Myers | Florida | Recruiting |
| Schiff Center for Liver Diseases/University of Miami | Miami | Florida | Recruiting |
| Covenant Metabolic Specialists, LLC | Sarasota | Florida | Recruiting |
| Florida Research Institute | Tampa | Florida | Recruiting |
| Piedmont Atlanta Hospital / Piedmont Transplant Institute | Atlanta | Georgia | Recruiting |
| Northwestern University | Chicago | Illinois | Recruiting |
| University of Chicago Medical Center | Chicago | Illinois | Recruiting |
| University Of Iowa Hospitals And Clinics | Iowa City | Iowa | Recruiting |
| University of Louisville, Clinical Trials Unit | Louisville | Kentucky | Recruiting |
| Ochsner Clinic Foundation | Jefferson | Louisiana | Recruiting |
| University Health System - East Jefferson General Hospital Campus | New Orleans | Louisiana | Recruiting |
| Mercy Medical Center | Baltimore | Maryland | Recruiting |
| Walter Reed National Military | Bethesda | Maryland | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | Recruiting |
| Henry Ford Medical Center - Columbus | Detroit | Michigan | Recruiting |
| University of Rochester Medical Center - Strong Memorial Hospital | Rochester | Minnesota | Recruiting |
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| Northwell Health Center for Liver Disease and Transplantation | Manhasset | New York | Recruiting |
| NYU Langone Health | New York | New York | Recruiting |
| New York-Presbyterian/Weill Cornell Medical Center | New York | New York | Recruiting |
| Mount Sinai | New York | New York | Recruiting |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | Recruiting |
| University Hosptials Cleveland Medical Center | Cleveland | Ohio | Recruiting |
| The Cleveland Clinic Foundation | Cleveland | Ohio | Recruiting |
| The Ohio State University Medical Center | Columbus | Ohio | Recruiting |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | Recruiting |
| University of Pennsylvania Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | Recruiting |
+ 177 more sites — see the full list on the official registry below.
More Gilead Sciences trials in France
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 NCT06051617 on ClinicalTrials.gov ↗ ← All trials in France