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RecruitingPhase 3

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

Gilead Sciences · NCT06051617

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
402
US sites recruiting
54
Study start
September 7, 2023
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Seladelpar; Placebo

Conditions: Primary Biliary Cholangitis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

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 primary biliary cholangitis (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)

Exclusion Criteria

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

Recruiting US locations

Study contacts (from the official record)

  • Gilead Clinical Study Information Center · 1-833-445-3230 (GILEAD-0) · GileadClinicalTrials@gilead.com
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and… (NCT06051617) | Bored Studies