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Use of Fenofibrate for Primary Biliary Cirrhosis

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ClinicalTrials.gov Identifier: NCT00575042
Recruitment Status : Completed
First Posted : December 17, 2007
Results First Posted : January 9, 2012
Last Update Posted : March 8, 2018
Sponsor:
Collaborators:
The PBCers Organization
Shionogi Inc.
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Primary Biliary Cirrhosis Drug: Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Fenofibrate for Primary Biliary Cirrhosis
Study Start Date : August 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2010


Arm Intervention/treatment
Experimental: Patients treated with Fenofibrate
Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) 160 mg table per day for 1 year
Drug: Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)
160 mg per day for 1 year
Other Name: Triglide-Insoluble Drug Delivery-Micro Particle Fenofibrate (IDD-P)



Primary Outcome Measures :
  1. Serum Level of Alkaline Phosphatase [ Time Frame: 1 year ]
    We analyzed whether there was a difference in median ALP at 1 year compared to baseline values.



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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
First Posted: December 17, 2007    Key Record Dates
Results First Posted: January 9, 2012
Last Update Posted: March 8, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
PBC
Primary Biliary Cirrhosis
Fenofibrate
Triglide

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Liver Cirrhosis, Biliary
Pathologic Processes
Liver Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents