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

Primary Purpose

Primary Biliary Cirrhosis

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fenofibrate
placebo
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Biliary Cirrhosis

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami
  • Mayo Clinic Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fenofibrate

sugar pill

Arm Description

Outcomes

Primary Outcome Measures

Serum alkaline phosphatase level

Secondary Outcome Measures

Symptoms - quality of life
Quality of life will be evaluated throught the NIDDK questionnaire at entry and end of study
symptoms - pruritus
Pruritus will be evaluated through a visual analogue scale and the 5-D questionnaire, both applied at entry and end of study
symptom -fatigue
fatigue will be evaluated through the Fatigue Impact Scale applied at entry and end of study
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.
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.

Full Information

First Posted
June 8, 2010
Last Updated
March 31, 2014
Sponsor
University of Miami
Collaborators
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01141296
Brief Title
Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis
Official Title
Randomized Controlled Study of Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
April 2011 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fenofibrate
Arm Type
Active Comparator
Arm Title
sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
fenofibrate
Intervention Description
fenofibrate 200 mg PO daily for 1 year
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo pill identical to active drug will be given PO once a day for 1 year
Primary Outcome Measure Information:
Title
Serum alkaline phosphatase level
Time Frame
one year
Secondary Outcome Measure Information:
Title
Symptoms - quality of life
Description
Quality of life will be evaluated throught the NIDDK questionnaire at entry and end of study
Time Frame
one year
Title
symptoms - pruritus
Description
Pruritus will be evaluated through a visual analogue scale and the 5-D questionnaire, both applied at entry and end of study
Time Frame
one year
Title
symptom -fatigue
Description
fatigue will be evaluated through the Fatigue Impact Scale applied at entry and end of study
Time Frame
one year
Title
interleukin 1
Description
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.
Time Frame
one year
Title
interleukin 6
Description
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.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 21 and ≤ 75 years old Established diagnosis of PBC and positive AMA Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year 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 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 Signed informed consent after careful review of information and study details Exclusion Criteria: Hypersensitivity to fenofibrate Administration of the following drugs at any time during the 3 months prior to screening for the study: methotrexate, colchicines, azathioprine, systemic steroids. Prisoners and institutionalized subjects, pregnant or nursing women Anticipated need for liver transplantation within one year (estimated 1-year survival <80% as predicted by the Mayo risk score). Recipients of liver transplantation Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites 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 Acute or chronic renal failure, defined as GFR < 60 ml/min Known history of cholecystitis with intact gallbladder History of, or known high risk for, venous thromboembolism Current use of warfarin or statins
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Levy, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States

12. IPD Sharing Statement

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

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