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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 Cholangitis

Interleukin 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

Page last updated: August 23, 2015

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