Primary Biliary Cirrhosis
Conditions
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.
Interventions
DRUGfenofibrate
fenofibrate 200 mg PO daily for 1 year
DRUGplacebo
Placebo pill identical to active drug will be given PO once a day for 1 year
Sponsors
Mayo Clinic
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum alkaline phosphatase level | one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms - quality of life | one year | Quality of life will be evaluated throught the NIDDK questionnaire at entry and end of study |
| symptoms - pruritus | one year | Pruritus will be evaluated through a visual analogue scale and the 5-D questionnaire, both applied at entry and end of study |
| symptom -fatigue | one year | fatigue will be evaluated through the Fatigue Impact Scale applied at entry and end of study |
| interleukin 1 | one year | 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 | one year | 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. |
Countries
United States
Outcome results
None listed