This clinical trial is focused on studying the effects of a medication called bezafibrate in patients with a liver disease known as Primary Sclerosing Cholangitis (PSC). PSC is a condition where the bile ducts, which carry digestive fluid from the liver to the small intestine, become inflamed and scarred, leading to liver damage. The study is specifically looking at patients who continue to have a condition called cholestasis, which is a reduction or stoppage of bile flow, despite being treated with a standard medication called ursodeoxycholic acid (UDCA).

The purpose of the study is to evaluate the effectiveness of bezafibrate over a period of 24 months. Participants in the study will be randomly assigned to receive either bezafibrate or a placebo, in addition to their usual UDCA treatment. A placebo is a substance with no active medication, used to compare the effects of the actual drug. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving bezafibrate and who is receiving the placebo, to ensure unbiased results.

Throughout the study, participants will continue their regular medical care and will have periodic check-ups to monitor their health and the effects of the treatment. The study aims to see if bezafibrate can help improve liver function and reduce symptoms in patients with PSC. The trial will last for two years, and participants will be closely monitored for any changes in their condition and overall health.