Pilot Study of Fenofibrate for PSC

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Primary Sclerosing Cholangitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fenofibrate

fenofibrate 160 mg po daily

Group Type EXPERIMENTAL

fenofibrate

Intervention Type DRUG

160 mg po daily

Interventions

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fenofibrate

160 mg po daily

Intervention Type DRUG

Eligibility Criteria

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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,

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No