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

Phase 2

Withdrawn

• Conditions: Primary Biliary Cirrhosis
• Interventions: Drug: placebo; Drug: fenofibrate

• Registration Number: NCT01141296
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-06-09
• Study First Posted: 2010-06-10
• Study Start: 2011-04
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-31
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sugar pill	placebo	-
Fenofibrate	fenofibrate	-

Primary Outcome Measures

Name	Time	Method
Serum alkaline phosphatase level	one year

Secondary Outcome Measures

Name	Time	Method
symptom -fatigue	one year	fatigue will be evaluated through the Fatigue Impact Scale applied at entry and end of study
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
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.

Trial Locations

Locations (2)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

University of Miami; 🇺🇸 Miami, Florida, United States