Tests seladelpar in people with primary biliary cholangitis and compensated cirrhosis
Tests seladelpar against placebo in adults with liver disease and cirrhosis.
Plain-language title generated from the registry record
Registry title: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Key facts
- Where
- Calgary, Edmonton, Montreal, Ottawa, Québec, Toronto, and Vancouver, CanadaSee the 7 sites
- Phase
- Phase 3
Where in Canada
- University Of CalgaryCalgary, CanadaTaking people
- University of AlbertaEdmonton, CanadaTaking people
- Centre Hospitalier de l'Université de MontréalMontreal, CanadaTaking people
- Ottawa HospitalOttawa, CanadaTaking people
- Diex Recherche - Québec - PPDSQuébec, CanadaTaking people
- Toronto General HospitalToronto, CanadaTaking people
- GI Research Institute FoundationVancouver, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gilead Sciences
- Trial code
- NCT06051617EU 2024-516525-31-01
- Record updated
- 2 November 2026
- Original description
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.Read full original descriptionShow less
AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
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.
Inclusion: 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: Prior exposure to seladelpar; Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI; History or presence of other concomitant liver diseases; 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; 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; Individuals must not meet any of the following criteria to be eligible for study participation:; Decompensated cirrhosis; Hospitalization for liver-related complication within 12 weeks of Screening; CP-C cirrhosis.