Use of Fenofibrate for Primary Biliary Cirrhosis - Full Text View

Sponsor:	University of Florida
Collaborators:	The PBCers Organization Shionogi Inc.
Information provided by (Responsible Party):	University of Florida
ClinicalTrials.gov Identifier:	NCT00575042

Purpose

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.

Condition	Intervention	Phase
Primary Biliary Cirrhosis	Drug: Fenofibrate (Insoluble Drug Delivery-Micro Particle Fenofibrate (IDD-P)	Phase II

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 for Primary Biliary Cirrhosis

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis progressive familial intrahepatic cholestasis

MedlinePlus related topics: Cirrhosis

Drug Information available for: Procetofen

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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

Enrollment:	20
Study Start Date:	August 2007
Study Completion Date:	August 2010
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Intervention Details:

160 mg per day

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

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.

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575042

Locations

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

University of Florida

The PBCers Organization

Shionogi Inc.

Investigators

Principal Investigator:

Cynthia Levy, MD

University of Florida

More Information

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.

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

Keywords provided by University of Florida:

PBC
Primary Biliary Cirrhosis
Fenofibrate
Triglide

Additional relevant MeSH terms:

Liver Cirrhosis, Biliary
Liver Cirrhosis
Fibrosis
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases

Pathologic Processes
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012