Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

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.

Timeline

Start

2016-04-08

Primary completion

2022-05-06

Completion

2022-06

Publications

• Liu Y, Guo G, Zheng L, Sun R, Wang X, Deng J, Jia G, Yang C, Cui L, Guo C, Shang Y, Han Y. Effectiveness of Fenofibrate in Treatment-Naive Patients With Primary Biliary Cholangitis: A Randomized Clinical Trial. Am J Gastroenterol. 2023 Nov 1;118(11):1973-1979. doi: 10.14309/ajg.0000000000002238. Epub 2023 Mar 9.

Drugs

Indications