Back to resultsUse of Fenofibrate for Primary Biliary Cirrhosis
Primary Purpose
Primary Biliary Cirrhosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)
Sponsored by
About this trial
This is an interventional treatment trial for Primary Biliary Cirrhosis focused on measuring PBC, Primary Biliary Cirrhosis, Fenofibrate, Triglide
Eligibility Criteria
Inclusion Criteria:
- Established diagnosis of PBC by serological (positive antimitochondrial antibodies) and/or histological evidence (diagnostic liver biopsy)
- Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year
- Persistent elevation of serum alkaline phosphatase ≥ 2 times the upper limit of normal on two separate measurements
- Female patients of childbearing age should have a pregnancy test done within -days of the beginning of this trial, and should agree to be on adequate contraception throughout the study period
- Signed informed consent after careful review of the information and study details by one of the investigators
Exclusion Criteria
- Hypersensitivity to fenofibrate
- Prisoners and institutionalized subjects
- Pregnant or nursing women
- Anticipated need for liver transplantation in one year (estimated one year survival < 80%) as determined by the Mayo risk score. The Mayo risk score takes into account the patient's age, serum bilirubin, albumin and prothrombin time, as well as presence or absence of peripheral edema.
- Recipients of liver transplantation
- Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
- Co-existing liver diseases, such as primary sclerosing cholangitis, acute or chronic hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, cholangiocarcinoma
- Acute or chronic renal failure
- Known history of cholecystitis with intact gallbladder
- Current use of statins, as the concomitant use of fibrates and statins would increase the risk of toxicity
Sites / Locations
- University of Florida
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients treated with Fenofibrate
Arm Description
Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) 160 mg table per day for 1 year
Outcomes
Primary Outcome Measures
Serum Level of Alkaline Phosphatase
We analyzed whether there was a difference in median ALP at 1 year compared to baseline values.
Secondary Outcome Measures
Full Information
NCT ID
NCT00575042
First Posted
December 13, 2007
Last Updated
February 7, 2018
Sponsor
University of Florida
Collaborators
The PBCers Organization, Shionogi Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00575042
Brief Title
Use of Fenofibrate for Primary Biliary Cirrhosis
Official Title
Pilot Study of Fenofibrate for Primary Biliary Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
The PBCers Organization, Shionogi Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.
Detailed Description
This is a multicenter open label pilot study to evaluate the efficacy of fenofibrate in 20 patients with PBC treated for 1 year. A randomized design would not be feasible at this stage of the research. Two sites are enrolling patients: University of Florida, Gainesville, and Mayo Clinic Rochester, with the first as the coordinating site. The total number of patients to start treatment will not exceed 20. Our endpoints are 1) surrogate markers of disease activity -serum alkaline phosphatase and immunoglobulin M; 2) a well validated prognostic index -Mayo risk score and 3) the NIDDK quality of life questionnaire.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cirrhosis
Keywords
PBC, Primary Biliary Cirrhosis, Fenofibrate, Triglide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients treated with Fenofibrate
Arm Type
Experimental
Arm Description
Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) 160 mg table per day for 1 year
Intervention Type
Drug
Intervention Name(s)
Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle)
Other Intervention Name(s)
Triglide-Insoluble Drug Delivery-Micro Particle Fenofibrate (IDD-P)
Intervention Description
160 mg per day for 1 year
Primary Outcome Measure Information:
Title
Serum Level of Alkaline Phosphatase
Description
We analyzed whether there was a difference in median ALP at 1 year compared to baseline values.
Time Frame
1 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:
Established diagnosis of PBC by serological (positive antimitochondrial antibodies) and/or histological evidence (diagnostic liver biopsy)
Previous treatment with UDCA 13-15 mg/kg/day for at least 1 year
Persistent elevation of serum alkaline phosphatase ≥ 2 times the upper limit of normal on two separate measurements
Female patients of childbearing age should have a pregnancy test done within -days of the beginning of this trial, and should agree to be on adequate contraception throughout the study period
Signed informed consent after careful review of the information and study details by one of the investigators
Exclusion Criteria
Hypersensitivity to fenofibrate
Prisoners and institutionalized subjects
Pregnant or nursing women
Anticipated need for liver transplantation in one year (estimated one year survival < 80%) as determined by the Mayo risk score. The Mayo risk score takes into account the patient's age, serum bilirubin, albumin and prothrombin time, as well as presence or absence of peripheral edema.
Recipients of liver transplantation
Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
Co-existing liver diseases, such as primary sclerosing cholangitis, acute or chronic hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, cholangiocarcinoma
Acute or chronic renal failure
Known history of cholecystitis with intact gallbladder
Current use of statins, as the concomitant use of fibrates and statins would increase the risk of toxicity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Levy, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Levy C, Peter J, Keach J, Petz J, Lindor KD, Cabrera R, et al. Fenofibrate improves liver biochemistries in primary biliary cirrhosis. Hepatology. 2009;50(4 (suppl)):995A.
Results Reference
background
PubMed Identifier
21083674
Citation
Levy C, Peter JA, Nelson DR, Keach J, Petz J, Cabrera R, Clark V, Firpi RJ, Morelli G, Soldevila-Pico C, Lindor K. Pilot study: fenofibrate for patients with primary biliary cirrhosis and an incomplete response to ursodeoxycholic acid. Aliment Pharmacol Ther. 2011 Jan;33(2):235-42. doi: 10.1111/j.1365-2036.2010.04512.x. Epub 2010 Nov 17.
Results Reference
result
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Use of Fenofibrate for Primary Biliary Cirrhosis
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