Pilot Study of Fenofibrate for PSC
| Status: | Terminated |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 2/8/2018 |
| Start Date: | October 2010 |
| End Date: | December 2012 |
Pilot Study of Fenofibrate in Primary Sclerosing Cholangitis
The purpose of this study is to determine whether fenofibrate is safe and effective in the
treatment primary sclerosing cholangitis (PSC).
treatment primary sclerosing cholangitis (PSC).
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,
We found this trial at
2
sites
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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University of Miami A private research university with more than 15,000 students from around the...
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