Pilot Study of Fenofibrate for PSC

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborator: University of Florida
• Treatments: Fenofibrate

Criteria

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,