Pilot Study of Fenofibrate for PSC

Study Overview
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Brief Summary
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The purpose of this study is to determine whether fenofibrate is safe and effective in the treatment primary sclerosing cholangitis (PSC).

Official Title
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Pilot Study of Fenofibrate in Primary Sclerosing Cholangitis

Conditions
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Primary Sclerosing Cholangitis

Intervention / Treatment
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* Drug: fenofibrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients of 18 to 75 years old Confirmed diagnosis of PSC including typical findings of stricturing and dilatations of the intra and/or extrahepatic biliary ducts in radiographic exam, (endoscopic retrograde cholangiopancreatography -ERCP, percutaneous cholangiogram - PTC or magnetic resonance cholangiopancreatography- MRCP) Serum alkaline phosphatase levels elevated to at least 1.5 times the upper limit of normal. Exclusion Criteria: Hypersensitivity to fenofibrate Prisoners and institutionalized subjects Pregnant or nursing women Anticipated need for liver transplantation in one year Recipients of liver transplantation Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites Co-existing liver diseases including auto-immune and viral hepatitis Acute or chronic renal failure, defined as glomerular filtration rate (GFR)< 60 ml/min, GFR calculated using the Modification of Diet in Renal Disease (MDRF) GFR calculator Known cholecystitis Current use of statins Current use of coumadin anticoagulant therapy Previous history of, or known high risk for, venous thromboembolism,

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fenofibrate<br>fenofibrate 160 mg po daily | Drug: fenofibrate<br>* 160 mg po daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Alkaline Phosphatase | Serum alkaline phosphatase will be measured at entry and end of study | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mayo Risk Score for Primary Sclerosing Cholangitis | The Mayo risk score (MRS), which is a composite of several variables (age, bilirubin, albumin, aspartate aminotransferase[AST] and h/o variceal bleeding), will be measured at entry and end of study. The MRS is a mathematically calculated risk score. MRS does not have a theoretical lower/upper bound (that is, no theoretical minimum and maximum values). Mayo risk score <=0 indicates low risk of death. MRS between 0 and 2 indicates intermediate risk, and greater than 2 indicates high risk. There is no known range for this score. | 6 months |