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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Primary Biliary Cirrhosis
Drug: fenofibrate
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Serum alkaline phosphatase level [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: April 2011
Arms Assigned Interventions
Active Comparator: Fenofibrate Drug: fenofibrate
fenofibrate 200 mg PO daily for 1 year
Placebo Comparator: sugar pill Drug: placebo
Placebo pill identical to active drug will be given PO once a day for 1 year

  Eligibility

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

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
  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: NCT01141296

Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55902
Sponsors and Collaborators
University of Miami
Mayo Clinic
Investigators
Principal Investigator: Cynthia Levy, MD University of Miami
  More Information

No publications provided

Responsible Party: Cynthia Levy, MD, University of Miami
ClinicalTrials.gov Identifier: NCT01141296     History of Changes
Other Study ID Numbers: Feno-01
Study First Received: June 8, 2010
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

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
Ursodeoxycholic Acid
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Cholagogues and Choleretics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 26, 2014