Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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) ≥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
