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Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis

This study has been withdrawn prior to enrollment.
(Lack of funding)
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Cynthia Levy, University of Miami
ClinicalTrials.gov Identifier:
NCT01141296
First received: June 8, 2010
Last updated: March 31, 2014
Last verified: March 2014

June 8, 2010
March 31, 2014
April 2011
Not Provided
Serum alkaline phosphatase level [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01141296 on ClinicalTrials.gov Archive Site
  • Symptoms - quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
    Quality of life will be evaluated throught the NIDDK questionnaire at entry and end of study
  • symptoms - pruritus [ Time Frame: one year ] [ Designated as safety issue: No ]
    Pruritus will be evaluated through a visual analogue scale and the 5-D questionnaire, both applied at entry and end of study
  • symptom -fatigue [ Time Frame: one year ] [ Designated as safety issue: No ]
    fatigue will be evaluated through the Fatigue Impact Scale applied at entry and end of study
  • interleukin 1 [ Time Frame: one year ] [ Designated as safety issue: No ]
    IL-1 will be measured from stored serum collected at entry and end of study. This will be measured by Beadlyte Human Multicytokine Detection system.
  • interleukin 6 [ Time Frame: one year ] [ Designated as safety issue: No ]
    IL-6 will be measured from stored serum collected at entry and end of study. This will be measured by Beadlyte Human Multicytokine Detection system.
Same as current
Not Provided
Not Provided
 
Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis
Randomized Controlled Study of Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

The purpose of this study is to determine if the combination of ursodeoxycholic acid (UDCA) and fenofibrate is more effective than UDCA alone in the treatment of primary biliary cirrhosis.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Primary Biliary Cirrhosis
  • Drug: fenofibrate
    fenofibrate 200 mg PO daily for 1 year
  • Drug: placebo
    Placebo pill identical to active drug will be given PO once a day for 1 year
  • Active Comparator: Fenofibrate
    Intervention: Drug: fenofibrate
  • Placebo Comparator: sugar pill
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

Inclusion Criteria:

  1. Age ≥ 21 and ≤ 75 years old
  2. Established diagnosis of PBC and positive AMA
  3. Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year
  4. Incomplete response to UDCA defined as serum ALP ≥ 2 times the upper limit of normal on two separate measurements despite at least 1 year of therapy with UDCA
  5. Female patients of childbearing age need a negative pregnancy test performed within 7 days of enrollment, and need to be on adequate contraception throughout the study period
  6. Signed informed consent after careful review of information and study details

Exclusion Criteria:

  1. Hypersensitivity to fenofibrate
  2. Administration of the following drugs at any time during the 3 months prior to screening for the study: methotrexate, colchicines, azathioprine, systemic steroids.
  3. Prisoners and institutionalized subjects, pregnant or nursing women
  4. Anticipated need for liver transplantation within one year (estimated 1-year survival <80% as predicted by the Mayo risk score).
  5. Recipients of liver transplantation
  6. Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
  7. Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis
  8. Acute or chronic renal failure, defined as GFR < 60 ml/min
  9. Known history of cholecystitis with intact gallbladder
  10. History of, or known high risk for, venous thromboembolism
  11. Current use of warfarin or statins
Both
21 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01141296
Feno-01
No
Cynthia Levy, University of Miami
University of Miami
Mayo Clinic
Principal Investigator: Cynthia Levy, MD University of Miami
University of Miami
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP