Fenofibrate for PSC
Information source: University of Miami
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Sclerosing Cholangitis
Intervention: fenofibrate (Drug)
Phase: Phase 1/Phase 2
Status: Terminated
Sponsored by: University of Miami Official(s) and/or principal investigator(s): Cynthia Levy, MD, Principal Investigator, Affiliation: University of Miami
Summary
The purpose of this study is to determine whether fenofibrate is safe and effective in the
treatment primary sclerosing cholangitis (PSC).
Clinical Details
Official title: Pilot Study of Fenofibrate in Primary Sclerosing Cholangitis
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Serum Alkaline Phosphatase
Secondary outcome: Mayo Risk Score for Primary Sclerosing CholangitisInterleukin 1 Interleukin 6
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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,
Locations and Contacts
University of Florida, Gainesville, Florida 32608, United States
University of Miami, Miami, Florida 33136, United States
Additional Information
Starting date: October 2010
Last updated: March 12, 2013
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