An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
117
Fenofibrate (200 mg/day)
Ursodeoxycholic acid (13-15 mg/kg/day)
Xijing Hospital
Xi'an, Shaanxi, China
RECRUITINGTreatment emergent adverse events (TEAEs)
Time frame: Through study completion, up to 120 Months
Percentage of patients with biochemical response
The normalisation of Alkaline Phosphatase
Time frame: Through study completion, up to 120 Months
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