ClinicaliQ Trial Snapshot
- Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis — Recruiting • Phase III • Gastroenterology • NCT06051617.
- To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
- Sponsor: Gilead Sciences.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
Eligibility Snapshot
- : 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
- Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.