Use of Fenofibrate for Primary Biliary Cirrhosis - Full Text View

Sponsors and Collaborators:	University of Florida PBCers Organization Sciele Pharma
Information provided by:	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

MedlinePlus related topics: Cirrhosis

Drug Information available for: Procetofen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Study of Fenofibrate for Primary Biliary Cirrhosis

Further study details as provided by University of Florida:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Quality of life according to NIDDK questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2010

Intervention Details:

160 mg per day

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

Contacts

Contact: Cynthia Levy, MD	352-376-1611 ext 7-5446	cynthia.levy@medicine.ufl.edu
Contact: Joy Peter, RN, BSN, CCRC	(352)392-7956	joy.peter@medicine.ufl.edu

Locations

United States, Florida
University of Florida	Recruiting
Gainesville, Florida, United States, 32610
Contact: Cynthia Levy, MD 352-376-1611 ext 7-5446 cynthia.levy@medicine.ufl.edu
Contact: Joy Peter, RN, BSN, CCRC 352-392-7956 joy.peter@medicine.ufl.edu
Principal Investigator: Cynthia Levy, MD
United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Roberta Jorgensen 507-538-0678 jorgensen.roberta@mayo.edu
Contact: Jill Keach (507)538-0678 keach.jill@mayo.edu
Principal Investigator: Keith Lindor, MD

Sponsors and Collaborators

University of Florida

PBCers Organization

Sciele Pharma

Investigators

Principal Investigator:

Cynthia Levy, MD

University of Florida

More Information

Responsible Party:	University of Florida ( Cythia Levy, MD )
Study ID Numbers:	405-2006
Study First Received:	December 13, 2007
Last Updated:	December 13, 2007
ClinicalTrials.gov Identifier:	NCT00575042
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

Study placed in the following topic categories:

Biliary cirrhosis
Liver Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Bile Duct Diseases
Cholestasis

Fibrosis
Biliary Tract Diseases
Liver Cirrhosis
Procetofen
Primary biliary cirrhosis
Liver Cirrhosis, Biliary

Additional relevant MeSH terms:

Antimetabolites
Pathologic Processes
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Antilipemic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009