NCT02823353

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis: a Randomized Control Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (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.

Conditions

• Primary Biliary Cirrhosis

Interventions

Type	Name	Description
DRUG	Fenofibrate	Fenofibrate 200mg/day
DRUG	UDCA	UDCA 13-15mg/kg/day

Timeline

• Start date: 2016-04-08
• Primary completion: 2022-05-06
• Completion: 2022-06-01
• First posted: 2016-07-06
• Last updated: 2023-03-08

Locations

1 site across 1 country: China