A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Trial of Fenofibrate in Treatment-NaFve Adults With Primary Biliary Cholangitis

What this Trial Is About

Researchers are evaluating the drug Fenofibrate for adults with Primary Biliary Cholangitis (PBC) who have not been treated previously. The study aims to find out if Fenofibrate helps the liver return to normal function better than the standard medication Ursodeoxycholic Acid (UDCA), and to assess the safety of Fenofibrate. This Phase 3 clinical trial is randomized, double-blind, and controlled by an active comparator, addressing important questions about treatment for PBC. Participants will be randomly assigned to take either Fenofibrate plus a UDCA placebo or UDCA plus a Fenofibrate placebo daily for 12 months. Neither participants nor their doctors will know which treatment they receive. The study includes five clinic visits at 1, 3, 6, 9, and 12 months for check-ups, blood tests, and questionnaires. Liver stiffness will be measured with a special scan during some visits, and participants will be encouraged to have optional liver biopsies at the beginning and end of the study. During the trial, researchers will monitor liver function through blood tests including ALP levels, and track changes in other liver-related enzymes and bilirubin. They will also assess symptoms like itching and liver stiffness. Safety will be closely watched by recording any treatment-related side effects from enrollment through the 12 months of treatment. Participants can expect regular visits, tests, and optional procedures to provide detailed information about their liver health throughout the study.

FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy