drugset / Trial / NCT02965911

Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA

NCT02965911

Phase 1/2 Withdrawn Beijing 302 Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy.

Timeline

Start
2016-01
Primary completion
2021-09-08
Completion
2021-09-08

Drugs

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