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RECRUITING
NCT02823366
PHASE3

Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid

Sponsor: Xijing Hospital of Digestive Diseases

View on ClinicalTrials.gov

Summary

Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. Both lab research and some clinical studies suggest that fenofibrate could improve cholestasis in multiple ways including reduce of bile acid synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a random, open and parallel clinical research to explore the effect of fenofibrate in the PBC treatment.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2016-01

Completion Date

2028-12

Last Updated

2026-10-30

Healthy Volunteers

No

Interventions

DRUG

Fenofibrate

DRUG

UDCA

Locations (1)

Xijing Hosipital

Xi'an, Shaanxi, China