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Pilot Study of Fenofibrate for PSC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01142323
Recruitment Status : Terminated
First Posted : June 11, 2010
Results First Posted : April 23, 2013
Last Update Posted : February 6, 2018
University of Florida
Information provided by (Responsible Party):
Cynthia Levy, University of Miami

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

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Drug: fenofibrate Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Fenofibrate in Primary Sclerosing Cholangitis
Study Start Date : October 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Fenofibrate
fenofibrate 160 mg po daily
Drug: fenofibrate
160 mg po daily

Primary Outcome Measures :
  1. Serum Alkaline Phosphatase [ Time Frame: 6 months ]
    Serum alkaline phosphatase will be measured at entry and end of study

Secondary Outcome Measures :
  1. Mayo Risk Score for Primary Sclerosing Cholangitis [ Time Frame: 6 months ]

    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01142323

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United States, Florida
University of Florida
Gainesville, Florida, United States, 32608
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
University of Florida
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Principal Investigator: Cynthia Levy, MD University of Miami
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Responsible Party: Cynthia Levy, Associate Professor of Clinical, University of Miami Identifier: NCT01142323    
Other Study ID Numbers: 20100533
First Posted: June 11, 2010    Key Record Dates
Results First Posted: April 23, 2013
Last Update Posted: February 6, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents