Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

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

Official Title

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

Details

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

Keywords

Primary Biliary Cholangitis, Primary Biliary Cholangitis (PBC), PBC, Cholangitis, Biliary Liver Cirrhosis, Seladelpar, Seladelpar 10 mg

Eligibility

You can join if…

Open to people ages 18-75

Subjects must meet the following criteria to be eligible for study participation:

  1. Must be 18 to 75 years old (inclusive)
  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 subjects 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. Subjects must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)

You CAN'T join if...

Subjects 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. ALP ≥10×ULN
    2. ALT or AST ≥5×ULN
    3. TB ≥5×ULN
    4. Platelet count ≤75×103/µL
    5. Albumin ≤2.8 g/dL
    6. Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2
    7. MELD score >12. For subjects on anticoagulation medication, baseline 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

Locations

  • Connie Frank Transplant center at UCSF accepting new patients
    San Francisco California 94143 United States
  • University of California, Davis Medical Center (Study Visits) accepting new patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CymaBay Therapeutics, Inc.
ID
NCT06051617
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 192 study participants
Last Updated