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

Overview

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

Description

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

Eligibility

Inclusion Criteria:

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)

Exclusion Criteria:

        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 ≤75×10^3/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 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