RecruitingPrimary Biliary Cholangitis

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

Eligible age

18+ yrs

Accepts

All genders

Locations

22 states

Healthy volunteers

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

Sponsor: Gilead Sciences

✓ 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)

✕ 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: