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

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.

Study Overview

• Status: Withdrawn
• Conditions: Primary Biliary Cirrhosis
• Intervention / Treatment: Drug: fenofibrate; Drug: placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: sugar pill	Drug: placebo; Placebo pill identical to active drug will be given PO once a day for 1 year
Active Comparator: Fenofibrate	Drug: fenofibrate; fenofibrate 200 mg PO daily for 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum alkaline phosphatase level	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms - quality of life	Quality of life will be evaluated throught the NIDDK questionnaire at entry and end of study	one year
symptoms - pruritus	Pruritus will be evaluated through a visual analogue scale and the 5-D questionnaire, both applied at entry and end of study	one year
symptom -fatigue	fatigue will be evaluated through the Fatigue Impact Scale applied at entry and end of study	one year
interleukin 1	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.	one year
interleukin 6	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.	one year

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Mayo Clinic
• Investigators: Principal Investigator: Cynthia Levy, MD, University of Miami

Study record dates

Study Major Dates

• Study Start: April 1, 2011

Study Registration Dates

• First Submitted: June 8, 2010
• First Submitted That Met QC Criteria: June 9, 2010
• First Posted (Estimate): June 10, 2010

Study Record Updates

• Last Update Posted (Estimate): April 2, 2014
• Last Update Submitted That Met QC Criteria: March 31, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis, Intrahepatic; Cholestasis; Fibrosis; Liver Cirrhosis; Liver Cirrhosis, Biliary; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fenofibrate
• Other Study ID Numbers: Feno-01