Use of Fenofibrate for Primary Biliary Cirrhosis

This study has been completed.

Sponsor:

Collaborators:

The PBCers Organization

Shionogi Inc.

Information provided by (Responsible Party):

University of Florida

ClinicalTrials.gov Identifier:

NCT00575042

First received: December 13, 2007

Last updated: December 2, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 13, 2007

Last Updated Date

December 2, 2011

Start Date ^ICMJE

August 2007

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Serum Level of Alkaline Phosphatase [ Time Frame: 1 year ] [ Designated as safety issue: No ]

We analyzed whether there was a difference in median ALP at 1 year compared to baseline values.

Original Primary Outcome Measures ^ICMJE

Serum level of alkaline phosphatase, serum immunoglobulin M level and Mayo risk score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00575042 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality of Life According to NIDDK Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Use of Fenofibrate for Primary Biliary Cirrhosis

Official Title ^ICMJE

Pilot Study of Fenofibrate for Primary Biliary Cirrhosis

Brief Summary

This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.

Detailed Description

This is a multicenter open label pilot study to evaluate the efficacy of fenofibrate in 20 patients with PBC treated for 1 year. A randomized design would not be feasible at this stage of the research. Two sites are enrolling patients: University of Florida, Gainesville, and Mayo Clinic Rochester, with the first as the coordinating site. The total number of patients to start treatment will not exceed 20. Our endpoints are 1) surrogate markers of disease activity -serum alkaline phosphatase and immunoglobulin M; 2) a well validated prognostic index -Mayo risk score and 3) the NIDDK quality of life questionnaire.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Primary Biliary Cirrhosis

Intervention ^ICMJE

Drug: Fenofibrate (Insoluble Drug Delivery-Micro Particle Fenofibrate (IDD-P)

160 mg per day

Other Name: Triglide-Insoluble Drug Delivery-Micro Particle Fenofibrate (IDD-P)

Study Arm (s)

Not Provided

Publications *

Levy C, Peter JA, Nelson DR, Keach J, Petz J, Cabrera R, Clark V, Firpi RJ, Morelli G, Soldevila-Pico C, Lindor K. Pilot study: fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid. Aliment Pharmacol Ther. 2011 Jan;33(2):235-42. Epub 2010 Nov 17.
Levy C, Peter J, Keach J, Petz J, Lindor KD, Cabrera R, et al. Fenofibrate improves liver biochemistries in primary biliary cirrhosis. Hepatology. 2009;50(4 (suppl)):995A.

* 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

Completed

Enrollment ^ICMJE

Completion Date

August 2010

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Established diagnosis of PBC by serological (positive antimitochondrial antibodies) and/or histological evidence (diagnostic liver biopsy)
Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year
Persistent elevation of serum alkaline phosphatase ≥ 2 times the upper limit of normal on two separate measurements
Female patients of childbearing age should have a pregnancy test done within -days of the beginning of this trial, and should agree to be on adequate contraception throughout the study period
Signed informed consent after careful review of the information and study details by one of the investigators

Exclusion Criteria

Hypersensitivity to fenofibrate
Prisoners and institutionalized subjects
Pregnant or nursing women
Anticipated need for liver transplantation in one year (estimated one year survival < 80%) as determined by the Mayo risk score. The Mayo risk score takes into account the patient's age, serum bilirubin, albumin and prothrombin time, as well as presence or absence of peripheral edema.
Recipients of liver transplantation
Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
Co-existing liver diseases, such as primary sclerosing cholangitis, acute or chronic hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, cholangiocarcinoma
Acute or chronic renal failure
Known history of cholecystitis with intact gallbladder
Current use of statins, as the concomitant use of fibrates and statins would increase the risk of toxicity

Gender

Both

Ages

21 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

NCT00575042

Other Study ID Numbers ^ICMJE

405-2006

Has Data Monitoring Committee

Responsible Party

University of Florida

Study Sponsor ^ICMJE

University of Florida

Collaborators ^ICMJE

The PBCers Organization
Shionogi Inc.

Investigators ^ICMJE

Principal Investigator:

Cynthia Levy, MD

University of Florida

Information Provided By

University of Florida

Verification Date

August 2011

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

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