AFFIRM (AFFIRM)

Study of Investigational Medication for Primary Biliary Cholangitis and Compensated Cirrhosis

Recruiting
18 years or above
All
Phase 3
318 participants needed
1 Location

Brief description of study

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

Detailed description of study

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

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Primary Biliary Cholangitis
  • Age: 18 years or above
  • Gender: All

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 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

This study investigates primary biliary cholangitis (PBC) and compensated cirrhosis. The purpose of this study is to understand how these conditions respond to an investigational medication.

The study evaluates the safety and effectiveness of the investigational medication in managing clinical outcomes for patients with PBC and compensated cirrhosis. It focuses on understanding the overall impact of the treatment on the health of participants.

  • Who can participate: Adults aged 18 or older with a confirmed diagnosis of primary biliary cholangitis and evidence of cirrhosis may be eligible. Participants must meet specific health criteria.
  • Study details: Participants will take the investigational medication as directed and attend regular study visits for health assessments. A placebo may be used in comparison.
Updated on 17 Jul 2026. Study ID: 25-1520

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