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 and fatigue
Change From Baseline in Fatigue and Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue and Pruritus. (0-10, higher scires mean a worse outcome)
Time frame: 1,3 and 6 months
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