drugset / Trial / NCT06174402

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis

NCT06174402

Phase 2/3 Active not recruiting 184 enrolled Han Ying
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC)

Timeline

Start
2023-08-21
Primary completion
2026-07
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Fenofibrate Small molecule 200 mg
Background Ursodeoxycholic Acid Small molecule 13 mg/kg
Background Ursodeoxycholic Acid Small molecule 15 mg/kg