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Fenofibrate for PSC

This study has been terminated.
University of Florida
Information provided by (Responsible Party):
Cynthia Levy, University of Miami Identifier:
First received: June 10, 2010
Last updated: May 10, 2017
Last verified: May 2017
The purpose of this study is to determine whether fenofibrate is safe and effective in the treatment primary sclerosing cholangitis (PSC).

Condition Intervention Phase
Primary Sclerosing Cholangitis Drug: fenofibrate Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Fenofibrate in Primary Sclerosing Cholangitis

Resource links provided by NLM:

Further study details as provided by Cynthia Levy, University of Miami:

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

Secondary Outcome Measures:
  • Mayo Risk Score for Primary Sclerosing Cholangitis [ Time Frame: 6 months ]
    The Mayo risk score, 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

  • Interleukin 1 [ Time Frame: 6 months ]
    Interleukin 1 will be measured at entry and end of study as an indirect measure of peroxisome proliferator- activated receptor alpha (PPAR- alpha) pathway activation.

  • Interleukin 6 [ Time Frame: 6 months ]
    Interleukin 6 will be measured at entry and end of study as an indirect measure of PPAR alpha pathway activation.

Enrollment: 8
Study Start Date: October 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fenofibrate
fenofibrate 160 mg po daily
Drug: fenofibrate
160 mg po daily


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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,
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01142323

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
Principal Investigator: Cynthia Levy, MD University of Miami
  More Information

Responsible Party: Cynthia Levy, Associate Professor of Clinical, University of Miami Identifier: NCT01142323     History of Changes
Other Study ID Numbers: Feno for PSC
Study First Received: June 10, 2010
Results First Received: March 12, 2013
Last Updated: May 10, 2017

Additional relevant MeSH terms:
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents processed this record on September 19, 2017