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
  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 2

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:


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:
    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)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Cholestasis
Cholestasis, Intrahepatic
Digestive System Diseases
Liver Diseases
Fenofibrate
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014