Status:
WITHDRAWN
Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Mayo Clinic
Conditions:
Primary Biliary Cirrhosis
Eligibility:
All Genders
21-75 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Age ≥ 21 and ≤ 75 years old
- Established diagnosis of PBC and positive AMA
- Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year
- 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
- 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
- Signed informed consent after careful review of information and study details
Exclusion
- Hypersensitivity to fenofibrate
- Administration of the following drugs at any time during the 3 months prior to screening for the study: methotrexate, colchicines, azathioprine, systemic steroids.
- Prisoners and institutionalized subjects, pregnant or nursing women
- Anticipated need for liver transplantation within one year (estimated 1-year survival \<80% as predicted by the Mayo risk score).
- Recipients of liver transplantation
- Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
- 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
- Acute or chronic renal failure, defined as GFR \< 60 ml/min
- Known history of cholecystitis with intact gallbladder
- History of, or known high risk for, venous thromboembolism
- Current use of warfarin or statins
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01141296
Start Date
April 1 2011
Last Update
April 2 2014
Active Locations (2)
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1
University of Miami
Miami, Florida, United States, 33136
2
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55902