The purpose of this study is to determine if the combination of ursodeoxycholic acid (UDCA) and fenofibrate is more effective than UDCA alone in the treatment of primary biliary cirrhosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
fenofibrate 200 mg PO daily for 1 year
Placebo pill identical to active drug will be given PO once a day for 1 year
University of Miami
Miami, Florida, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Serum alkaline phosphatase level
Time frame: one year
Symptoms - quality of life
Quality of life will be evaluated throught the NIDDK questionnaire at entry and end of study
Time frame: one year
symptoms - pruritus
Pruritus will be evaluated through a visual analogue scale and the 5-D questionnaire, both applied at entry and end of study
Time frame: one year
symptom -fatigue
fatigue will be evaluated through the Fatigue Impact Scale applied at entry and end of study
Time frame: one year
interleukin 1
IL-1 will be measured from stored serum collected at entry and end of study. This will be measured by Beadlyte Human Multicytokine Detection system.
Time frame: one year
interleukin 6
IL-6 will be measured from stored serum collected at entry and end of study. This will be measured by Beadlyte Human Multicytokine Detection system.
Time frame: one year
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