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

Primary Biliary Cirrhosis Clinical Trial

Official title:

Randomized Controlled Study of Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01141296
• Other study ID #: Feno-01
• Status: Withdrawn
• Phase: Phase 2
• First received: June 8, 2010
• Last updated: March 31, 2014
• Start date: April 2011

Study information

• Verified date: March 2014
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis

Intervention

Drug:
• fenofibrate
fenofibrate 200 mg PO daily for 1 year
• placebo
Placebo pill identical to active drug will be given PO once a day for 1 year

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum alkaline phosphatase level		one year	No
Secondary	Symptoms - quality of life	Quality of life will be evaluated throught the NIDDK questionnaire at entry and end of study	one year	No
Secondary	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	No
Secondary	symptom -fatigue	fatigue will be evaluated through the Fatigue Impact Scale applied at entry and end of study	one year	No
Secondary	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	No
Secondary	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	No