Study Stopped
Lack of funding
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
1 other identifier
interventional
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2010
CompletedFirst Posted
Study publicly available on registry
June 10, 2010
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedApril 2, 2014
March 1, 2014
June 8, 2010
March 31, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Serum alkaline phosphatase level
one year
Secondary Outcomes (5)
Symptoms - quality of life
one year
symptoms - pruritus
one year
symptom -fatigue
one year
interleukin 1
one year
interleukin 6
one year
Study Arms (2)
Fenofibrate
ACTIVE COMPARATORsugar pill
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Mayo Cliniccollaborator
Study Sites (2)
University of Miami
Miami, Florida, 33136, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55902, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia Levy, MD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 8, 2010
First Posted
June 10, 2010
Study Start
April 1, 2011
Last Updated
April 2, 2014
Record last verified: 2014-03