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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Primary Biliary Cholangitis

In brief

To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.

Key facts

Study ID

NCT06051617

Run by

Gilead Sciences

People needed

318

Starts

2023-09-07

Expected to finish

2030-08-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals must meet the following criteria to be eligible for study participation:
• Must be at least 18 years old.
• Must have a confirmed prior diagnosis of PBC
• Evidence of cirrhosis
• CP Score A or B
• 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
• Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)

You may not qualify if…

• Individuals must not meet any of the following criteria to be eligible for study participation:
• Prior exposure to seladelpar
• A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study
• History of liver transplantation or actively listed for cadaveric or planned living donor transplant.
• Decompensated cirrhosis
• Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI
• Hospitalization for liver-related complication within 12 weeks of Screening
• Laboratory parameters at Screening:
• Alkaline phosphatase (ALP) < 1.5× Upper limit of normal (ULN) or ≥ 10×ULN
• Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN
• Total bilirubin (TB) ≤ 0.6 × ULN or ≥ 5 × ULN
• Platelet count ≤50×10\^3/µL
• Albumin ≤2.8 g/dL
• Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m\^2
• 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.
• Serum alpha-fetoprotein (AFP) >20 ng/mL
• INR >1.7
• CP-C cirrhosis
• History or presence of other concomitant liver diseases

Where it is running

• St. Joseph's Hospital and Medical Center - 350 W. Thomas — Phoenix, Arizona, United States (enrolling)
• OM Research LLC — Lancaster, California, United States (enrolling)
• SCPMG/Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States (enrolling)
• Cedar Sinai Medical Center — Los Angeles, California, United States (enrolling)
• California Liver Research Institute — Pasadena, California, United States (enrolling)
• Stanford University — Redwood City, California, United States (enrolling)
• University of California, Davis Medical Center — Sacramento, California, United States (enrolling)
• California Pacific Medical Center - Sutter Pacific Medical Foundation — San Francisco, California, United States (enrolling)
• Connie Frank Transplant Center at UCSF — San Francisco, California, United States (enrolling)
• Kaiser Permanente - South San Francisco Medical Center — South San Francisco, California, United States (enrolling)
• Covenant Metabolic Specialists, LLC — Fort Myers, Florida, United States (enrolling)
• Schiff Center for Liver Diseases/University of Miami — Miami, Florida, United States (enrolling)
• Covenant Metabolic Specialists, LLC — Sarasota, Florida, United States (enrolling)
• Florida Research Institute — Tampa, Florida, United States (enrolling)
• Piedmont Atlanta Hospital / Piedmont Transplant Institute — Atlanta, Georgia, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• University Of Iowa Hospitals And Clinics — Iowa City, Iowa, United States (enrolling)
• University of Louisville, Clinical Trials Unit — Louisville, Kentucky, United States (enrolling)
• Ochsner Clinic Foundation — Jefferson, Louisiana, United States (enrolling)
• University Health System - East Jefferson General Hospital Campus — New Orleans, Louisiana, United States (enrolling)
• Mercy Medical Center — Baltimore, Maryland, United States (enrolling)
• Walter Reed National Military — Bethesda, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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