Primary Biliary Cholangitis (PBC) is a liver disease where the bile ducts are slowly destroyed. This study tests a drug called Seladelpar to see if it is safe and comfortable to use over a long time. It also checks if it helps with the symptoms of PBC, like itching.
To join the study, you need to have been in a previous PBC study with Seladelpar. If you're a woman who can have babies, you need to use two types of birth control during the study and for 90 days after. Men also need to use birth control.
You cannot join if you have had serious side effects from Seladelpar before, have certain other medical conditions, or are pregnant. Some medicines are not allowed during the study, and you cannot have certain viral infections.
- The study is long-term and ongoing.
- Participants need to have been involved in a previous Seladelpar PBC study.
- Women must use two forms of birth control, and men must use one.