Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.
| Condition(s) | Primary Biliary Cholangitis |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis. |
| Who can participate | 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 sc |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Gilead Sciences |
| Locations | Birmingham, Alabama, United States; Phoenix, Arizona, United States; Lancaster, California, United States; Los Angeles, California, United States; Los Angeles, California, United States; Pasadena, California, United States (+193 more sites) |
| Start date | 2023-09-07 |
| NCT ID | NCT06051617 |
| Official listing | https://clinicaltrials.gov/study/NCT06051617 |