Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
Status:
Unknown status
Trial end date:
2018-07-01
Target enrollment:
Participant gender:
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.