Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis (AFFIRM)
Primary Biliary Cholangitis
About this trial
This is an interventional treatment trial for Primary Biliary Cholangitis focused on measuring Primary Biliary Cholangitis (PBC), PBC
Eligibility Criteria
Inclusion Criteria: Subjects must meet the following criteria to be eligible for study participation: Must be 18 to 75 years old (inclusive) Must have a confirmed prior diagnosis of 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 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 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: Prior exposure to seladelpar 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. Decompensated cirrhosis Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI Hospitalization for liver-related complication within 12 weeks of Screening Laboratory parameters at Screening: ALP ≥10×ULN ALT or AST ≥5×ULN TB ≥5×ULN Platelet count ≤75×10^3/µL Albumin ≤2.8 g/dL Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m^2 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. Serum alpha-fetoprotein (AFP) >20 ng/mL INR >1.7 CP-C cirrhosis History or presence of other concomitant liver diseases
Sites / Locations
- Om Research LLCRecruiting
- California Liver Research CenterRecruiting
- Florida Research Institute, LLCRecruiting
- Mercy Medical CenterRecruiting
- University Hospitals Cleveland Medical CenterRecruiting
- The Liver Institute at Methodist Dallas Medical CenterRecruiting
- VCU Health Clinical Research Services Unit (CRSU)Recruiting
- Liver Institute NorthwestRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Seladelpar 10 mg
Placebo