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

NCT ID: NCT01141296

Last Updated: 2014-04-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30

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.

Conditions

Primary Biliary Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Fenofibrate

Group Type: ACTIVE_COMPARATOR

fenofibrate

Intervention Type: DRUG

fenofibrate 200 mg PO daily for 1 year

sugar pill

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Placebo pill identical to active drug will be given PO once a day for 1 year

Interventions

fenofibrate

fenofibrate 200 mg PO daily for 1 year

Intervention Type: DRUG

placebo

Placebo pill identical to active drug will be given PO once a day for 1 year

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Cynthia Levy

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cynthia Levy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

Feno-01

Identifier Type: -

Identifier Source: org_study_id