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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01141296
• Date of registration: 08/06/2010
• Prospective Registration: Yes
• Primary sponsor: University of Miami
• Public title: Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis
• Scientific title: Randomized Controlled Study of Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
• Date of first enrolment: April 2011
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01141296
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Cynthia Levy, MD
• Affiliation: University of Miami

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Biliary Cirrhosis

Intervention(s)

Drug: fenofibrate

Drug: placebo

Primary Outcome(s)

Serum alkaline phosphatase level [Time Frame: one year]

Secondary Outcome(s)

interleukin 6 [Time Frame: one year]

interleukin 1 [Time Frame: one year]

symptom -fatigue [Time Frame: one year]

Symptoms - quality of life [Time Frame: one year]

symptoms - pruritus [Time Frame: one year]

Secondary ID(s)

Feno-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mayo Clinic