The study drug, Ocaliva (OCA), already has FDA approval but we need to gather more data about how well it works on patients with Primary Biliary Cholangitis (PBC) when given along with the usual care for this condition. Half of the study participants will get the study drug and half will get a placebo (fake pill). You cannot choose or know which pill group you belong to.
There will be 2 clinic visits to decide if you can be enrolled. In the first year there are 7 visits and 4 visits each year after that. The study doctor will tell you when and how many pills to take each week. You may need other visits if the study doctor thinks it's necessary. At these visits you will be checked by interview, physical exam, blood and urine tests for medical changes. EKGs and abdominal tests will be done at some visits.
What we're hoping for
To learn more about how well the study drug Ocaliva (OCA) works in preventing or delaying specific medical conditions or health related issues that can occur in patients with PCB.
ClinicalTrials.gov Identifier: NCT02308111