Pilot Study of Fenofibrate for PSC

Phase 2TerminatedNCT01142323

University of Miami8 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Sclerosing Cholangitis

Interventions

fenofibrateDRUG

160 mg po daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 (2)

University of Florida

Gainesville, Florida, United States

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Serum Alkaline Phosphatase

Serum alkaline phosphatase will be measured at entry and end of study

Time frame: 6 months

Secondary Outcomes

Mayo Risk Score for Primary Sclerosing Cholangitis

The Mayo risk score (MRS), which is a composite of several variables (age, bilirubin, albumin, aspartate aminotransferase\[AST\] and h/o variceal bleeding), will be measured at entry and end of study. The MRS is a mathematically calculated risk score. MRS does not have a theoretical lower/upper bound (that is, no theoretical minimum and maximum values). Mayo risk score \<=0 indicates low risk of death. MRS between 0 and 2 indicates intermediate risk, and greater than 2 indicates high risk. There is no known range for this score.

Time frame: 6 months

Data from ClinicalTrials.gov

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