RecruitingPhase 3

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

United States318 participantsStarted 2023-09-07

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Must be at least 18 years old.
✓. 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 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
✓. Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)

✕. 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:
✕. Alkaline phosphatase (ALP) \< 1.5× Upper limit of normal (ULN) or ≥ 10×ULN

Event Free Survival (EFS)

Timeframe: 36 months

NCT IDNCT06051617

SponsorGilead Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-08

Gilead Clinical Study Information Center

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Must be at least 18 years old.
✓. 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 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
✓. Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)

✕. 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:
✕. Alkaline phosphatase (ALP) \< 1.5× Upper limit of normal (ULN) or ≥ 10×ULN