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

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