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Clinical Trials in the USA / NCT06051617
Recruiting Phase 3

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

NCT06051617 · tracked via the Priya Life Science USA tracker
Sponsor
Gilead Sciences
Phase
Phase 3
Started
2023-09-07
Last updated
2026-09-15

Condition(s) studied

Primary Biliary Cholangitis

Investigational drug(s) / intervention(s)

SeladelparPlacebo

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Individuals must meet the following criteria to be eligible for study participation: 1. Must be at least 18 years old. 2. Must have a confirmed prior diagnosis of primary biliary cholangitis (PBC) 3. Evidence of cirrhosis 4. CP Score A or B 5. Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose 6. Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA) Exclusion Criteria: Individuals must not meet any of the following criteria to be eligible for study participation: 1. Prior exposure to seladelpar 2. A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study 3. History of liver transplantation or actively listed for cadaveric or planned living donor transplant. 4. Decompensated cirrhosis 5. Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI 6. Hospitalization for liver-related complication within 12 weeks of Screening 7. Laboratory parameters at Screening: 1. Alkaline phosphatase (ALP) \< 1.5× Upper limit of normal (ULN) or ≥ 10×ULN 2. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN 3. Total bilirubin (TB) ≤ 0.6 × ULN or ≥ 5 × ULN 4. Platelet count ≤50×10\^3/µL 5. Albumin ≤2.8 g/dL 6. Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m\^2 7. MELD score \>12. For individuals on anticoagulation medication, baseline International normalized ratio (INR) determination for MELD score calculation should take anticoagulant use into account, in consultation with the Medical Monitor. 8. Serum alpha-fetoprotein (AFP) \>20 ng/mL 9. INR \>1.7 8. CP-C cirrhosis 9. History or presence of other concomitant liver diseases

Primary outcome measure(s)

Trial sites (213)

FacilityCityRegionStatus
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
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
Thomas Jefferson University Philadelphia Pennsylvania Recruiting

+ 173 more sites — see the full list on the official registry below.

Official registry record

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 the USA