Use of Fenofibrate for Primary Biliary Cirrhosis

This study has been completed.

Study NCT00575042 Information provided by University of Florida

First Received on December 13, 2007. Last Updated on December 2, 2011 History of Changes

Results First Received: December 2, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Primary Biliary Cirrhosis
Intervention:	Drug: Fenofibrate (Insoluble Drug Delivery-Micro Particle Fenofibrate (IDD-P)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from the liver clinics at University of Florida and Mayo Clinic Rochester.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Patients Treated With Fenofibrate	No text entered.

Participant Flow: Overall Study

	Patients Treated With Fenofibrate
STARTED	20
COMPLETED	17 ^[1]
NOT COMPLETED	3
Adverse Event	2
Lost to Follow-up	1

[1]	2 with side effects and 1 lost to follow-up

Baseline Characteristics

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Reporting Groups

	Description
Patients Treated With Fenofibrate	No text entered.

Baseline Measures

	Patients Treated With Fenofibrate
Number of Participants [units: participants]	20
Age [units: participants]
<=18 years	0
Between 18 and 65 years	17
>=65 years	3
Age [units: years] Mean ± Standard Deviation	54 ± 8.9
Gender [units: participants]
Female	16
Male	4
Region of Enrollment [units: participants]
United States	20

Outcome Measures

1. Primary:

Serum Level of Alkaline Phosphatase [ Time Frame: 1 year ]

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2. Secondary:

Quality of Life According to NIDDK Questionnaire [ Time Frame: 1 year ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
A major limitation is the uncontrolled nature of this study.

Results Point of Contact:

Name/Title: Dr. Cynthia Levy
Organization: University of Miami
phone: 305-243-2330
e-mail: clevy@med.miami.edu

Publications of Results:

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.

Other Publications:

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.

Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT00575042 History of Changes
Other Study ID Numbers:	405-2006
Study First Received:	December 13, 2007
Results First Received:	December 2, 2011
Last Updated:	December 2, 2011
Health Authority:	United States: Food and Drug Administration; United States: University of Florida Health Center Institutional Review Board