This study is a prospective, single center, randomized controlled, exploratory clinical trial aimed at evaluating the efficacy and safety of fenofibrate in newly diagnosed PBC subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Fenofibrate 200mg/day
UDCA 13-15mg/kg/day
Xijing hospital
Xi'an, Shaanxi, China
Percentage of patients with biochemical response
The normalisation of Alkaline Phosphatase
Time frame: 6 months
Percentage of patients having biochemical response
The normalisation of Alkaline Phosphatase
Time frame: 1 and 3 months
Assessment of the pruritus
Change From Baseline in Pruritus as Assessed by NRS Total Score for Fatigue and Pruritus. (0-10, higher scires mean a worse outcome)
Time frame: 6 months
The changes of liver function indicators
The changes of liver function indicators compared to baseline: ALP, ALT, AST, GGT, TBA, TBIL
Time frame: 1, 3 and 6 months
The percentage of patients achieving biochemical response criteria
The percentage of patients who meet various biochemical response criteria (Paris I, Paris II, and Barcelona, etc.)
Time frame: 1, 3 and 6 months
Prognostic score
GLOBE score
Time frame: 1, 3 and 6 month
Prognostic score
UK-PBC score
Time frame: 1, 3 and 6 month
Liver stiffness (LSM)
Evaluate the changes in LSM
Time frame: 1, 3 and 6 months
Event-free survival
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Liver transplantation and decompensation events-free survival
Time frame: From enrollment to the end of treatment at 6 months