Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.