Pilot Study of Fenofibrate for PSC

Stopped early · Phase 1/Phase 2

Conditions studied: Primary Sclerosing Cholangitis

In brief

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

Key facts

Study ID

NCT01142323

Run by

University of Miami

People needed

8

Starts

2010-10-01

Expected to finish

2012-12-01

Last updated by the study team

2018-02-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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,

Where it is running

• University of Florida — Gainesville, Florida, United States
• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.