An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Fenofibrate 200mg
Xijing Hospital
Xi'an, Shaanxi, China
Treatment emergent adverse events (TEAEs)
Time frame: Through study completion, up to 120 Months
Normalization of ALP
Percentage of patients having normalization of ALP
Time frame: From enrollment to the end of treatment at 120 months
The changes of liver function indicators
The changes of liver function indicators compared to baseline: ALP, ALT, AST, GGT, TBIL
Time frame: From enrollment to the end of treatment at 120 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: From enrollment to the end of treatment at 120 months
Death
Occurrence of overall death
Time frame: From enrollment to the end of treatment at 120 months
Liver transplantation
Occurrence of overall liver transplantation
Time frame: From enrollment to the end of treatment at 120 months
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