Pilot Study of Fenofibrate for PSC
Primary Purpose
Primary Sclerosing Cholangitis
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
fenofibrate
Sponsored by
About this trial
This is an interventional treatment trial for Primary Sclerosing Cholangitis
Eligibility Criteria
Inclusion Criteria:
- Male and female patients of 18 to 75 years old
- Confirmed diagnosis of PSC including typical findings of stricturing and dilatations of the intra and/or extrahepatic biliary ducts in radiographic exam, (endoscopic retrograde cholangiopancreatography -ERCP, percutaneous cholangiogram - PTC or magnetic resonance cholangiopancreatography- MRCP)
- Serum alkaline phosphatase levels elevated to at least 1.5 times the upper limit of normal.
Exclusion Criteria:
- Hypersensitivity to fenofibrate
- Prisoners and institutionalized subjects
- Pregnant or nursing women
- Anticipated need for liver transplantation in one year
- Recipients of liver transplantation
- Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
- Co-existing liver diseases including auto-immune and viral hepatitis
- Acute or chronic renal failure, defined as glomerular filtration rate (GFR)< 60 ml/min, GFR calculated using the Modification of Diet in Renal Disease (MDRF) GFR calculator
- Known cholecystitis
- Current use of statins
- Current use of coumadin anticoagulant therapy
- Previous history of, or known high risk for, venous thromboembolism,
Sites / Locations
- University of Florida
- University of Miami
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fenofibrate
Arm Description
fenofibrate 160 mg po daily
Outcomes
Primary Outcome Measures
Serum Alkaline Phosphatase
Serum alkaline phosphatase will be measured at entry and end of study
Secondary Outcome Measures
Mayo Risk Score for Primary Sclerosing Cholangitis
The Mayo risk score (MRS), which is a composite of several variables (age, bilirubin, albumin, aspartate aminotransferase[AST] and h/o variceal bleeding), will be measured at entry and end of study. The MRS is a mathematically calculated risk score.
MRS does not have a theoretical lower/upper bound (that is, no theoretical minimum and maximum values).
Mayo risk score <=0 indicates low risk of death. MRS between 0 and 2 indicates intermediate risk, and greater than 2 indicates high risk.
There is no known range for this score.
Full Information
NCT ID
NCT01142323
First Posted
June 10, 2010
Last Updated
February 3, 2018
Sponsor
University of Miami
Collaborators
University of Florida
1. Study Identification
Unique Protocol Identification Number
NCT01142323
Brief Title
Pilot Study of Fenofibrate for PSC
Official Title
Pilot Study of Fenofibrate in Primary Sclerosing Cholangitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
University of Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether fenofibrate is safe and effective in the treatment primary sclerosing cholangitis (PSC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fenofibrate
Arm Type
Experimental
Arm Description
fenofibrate 160 mg po daily
Intervention Type
Drug
Intervention Name(s)
fenofibrate
Intervention Description
160 mg po daily
Primary Outcome Measure Information:
Title
Serum Alkaline Phosphatase
Description
Serum alkaline phosphatase will be measured at entry and end of study
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mayo Risk Score for Primary Sclerosing Cholangitis
Description
The Mayo risk score (MRS), which is a composite of several variables (age, bilirubin, albumin, aspartate aminotransferase[AST] and h/o variceal bleeding), will be measured at entry and end of study. The MRS is a mathematically calculated risk score.
MRS does not have a theoretical lower/upper bound (that is, no theoretical minimum and maximum values).
Mayo risk score <=0 indicates low risk of death. MRS between 0 and 2 indicates intermediate risk, and greater than 2 indicates high risk.
There is no known range for this score.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients of 18 to 75 years old
Confirmed diagnosis of PSC including typical findings of stricturing and dilatations of the intra and/or extrahepatic biliary ducts in radiographic exam, (endoscopic retrograde cholangiopancreatography -ERCP, percutaneous cholangiogram - PTC or magnetic resonance cholangiopancreatography- MRCP)
Serum alkaline phosphatase levels elevated to at least 1.5 times the upper limit of normal.
Exclusion Criteria:
Hypersensitivity to fenofibrate
Prisoners and institutionalized subjects
Pregnant or nursing women
Anticipated need for liver transplantation in one year
Recipients of liver transplantation
Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
Co-existing liver diseases including auto-immune and viral hepatitis
Acute or chronic renal failure, defined as glomerular filtration rate (GFR)< 60 ml/min, GFR calculated using the Modification of Diet in Renal Disease (MDRF) GFR calculator
Known cholecystitis
Current use of statins
Current use of coumadin anticoagulant therapy
Previous history of, or known high risk for, venous thromboembolism,
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 Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
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Pilot Study of Fenofibrate for PSC
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