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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 10, 2010

Last Updated Date

March 12, 2013

Start Date ^ICMJE

October 2010

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Serum Alkaline Phosphatase [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01142323 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

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, 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 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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Fenofibrate for PSC

Official Title ^ICMJE

Pilot Study of Fenofibrate in Primary Sclerosing Cholangitis

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Primary Sclerosing Cholangitis

Intervention ^ICMJE

Drug: fenofibrate

160 mg po daily

Study Arm (s)

Experimental: Fenofibrate

fenofibrate 160 mg po daily

Intervention: Drug: fenofibrate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

December 2012

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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,

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01142323

Other Study ID Numbers ^ICMJE

Feno for PSC

Has Data Monitoring Committee

Responsible Party

Cynthia Levy, University of Miami

Study Sponsor ^ICMJE

University of Miami

Collaborators ^ICMJE

University of Florida

Investigators ^ICMJE

Principal Investigator:

Cynthia Levy, MD

University of Miami

Information Provided By

University of Miami

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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