Fenofibrate for PSC

This study has been terminated.
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
Cynthia Levy, University of Miami
ClinicalTrials.gov Identifier:
NCT01142323
First received: June 10, 2010
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 University of Miami:

Primary Outcome Measures:
  • Serum Alkaline Phosphatase [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Interleukin 6 will be measured at entry and end of study as an indirect measure of PPAR alpha pathway activation.


Enrollment: 9
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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,
  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 ClinicalTrials.gov identifier: NCT01142323

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

No publications provided

Responsible Party: Cynthia Levy, Associate Professor of Clinical, University of Miami
ClinicalTrials.gov 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: March 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Fenofibrate
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014