Pilot Study of Fenofibrate for PSC
- Registration Number
- NCT01142323
- Lead Sponsor
- University of Miami
- Brief Summary
The purpose of this study is to determine whether fenofibrate is safe and effective in the treatment primary sclerosing cholangitis (PSC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- 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.
- 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,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fenofibrate fenofibrate fenofibrate 160 mg po daily
- Primary Outcome Measures
Name Time Method Serum Alkaline Phosphatase 6 months Serum alkaline phosphatase will be measured at entry and end of study
- Secondary Outcome Measures
Name Time Method Mayo Risk Score for Primary Sclerosing Cholangitis 6 months 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.
Trial Locations
- Locations (2)
University of Miami
🇺🇸Miami, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States