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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
117
Fenofibrate 200mg/day
UDCA 13-15mg/kg/day
Xijing Hosipital
Xi'an, Shaanxi, China
Rate of patients with complete biochemical response
Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.
Time frame: Week 48
Change in liver biopsy examinations according to conventional Ludwig system.
Histological evolution will be checked by liver biopsy at the end of the study to compare with baseline histological status. The Ludwig histological classification schemes will be used, which categorised the disease into four stages.
Time frame: Week 48
GLOBE risk scores at week 48.
The prognostic scores will be calculated at end of the study by GLOBE scoring system (proposed by Global PBC Study Group), which calculated based on serum values of bilirubin, ALP, albumin and platelet count after 1 year of UDCA therapy and age at baseline.
Time frame: Week 48
Change in liver stiffness status measured by magnetic resonance elastography.
The change of liver stiffness status at the end of the study compared to baseline checked by magnetic resonance elastography.
Time frame: Week 48
Change in serum levels of ALP compared to the baseline.
Absolute change in serum levels of ALP compared to the baseline.
Time frame: Weeks 0, 4, 8, 12, 24, and 48
Change in serum levels of bilirubin compared to the baseline.
Absolute change in serum levels of bilirubin compared to the baseline.
Time frame: Weeks 0, 4, 8, 12, 24, and 48
Change in serum levels of transaminase compared to the baseline.
Absolute change in serum levels of transaminase compared to the baseline.
Time frame: Weeks 0, 4, 8, 12, 24, and 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.