Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Study of Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Conditions
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Primary Biliary Cirrhosis

Intervention / Treatment
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* Drug: fenofibrate
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 21 and ≤ 75 years old Established diagnosis of PBC and positive AMA Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year Incomplete response to UDCA defined as serum ALP ≥ 2 times the upper limit of normal on two separate measurements despite at least 1 year of therapy with UDCA Female patients of childbearing age need a negative pregnancy test performed within 7 days of enrollment, and need to be on adequate contraception throughout the study period Signed informed consent after careful review of information and study details Exclusion Criteria: Hypersensitivity to fenofibrate Administration of the following drugs at any time during the 3 months prior to screening for the study: methotrexate, colchicines, azathioprine, systemic steroids. Prisoners and institutionalized subjects, pregnant or nursing women Anticipated need for liver transplantation within one year (estimated 1-year survival <80% as predicted by the Mayo risk score). Recipients of liver transplantation Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis Acute or chronic renal failure, defined as GFR < 60 ml/min Known history of cholecystitis with intact gallbladder History of, or known high risk for, venous thromboembolism Current use of warfarin or statins

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fenofibrate<br> | Drug: fenofibrate<br>* fenofibrate 200 mg PO daily for 1 year<br>|
| Placebo Comparator: sugar pill<br> | Drug: placebo<br>* Placebo pill identical to active drug will be given PO once a day for 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum alkaline phosphatase level |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms - quality of life | Quality of life will be evaluated throught the NIDDK questionnaire at entry and end of study | 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 | one year | 
| symptom -fatigue | fatigue will be evaluated through the Fatigue Impact Scale applied at entry and end of study | 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. | 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. | one year |