Pilot Study of Fenofibrate for PSC
Pilot Study of Fenofibrate in Primary Sclerosing Cholangitis
1 other identifier
interventional
8
1 country
2
Brief Summary
The purpose of this study is to determine whether fenofibrate is safe and effective in the treatment primary sclerosing cholangitis (PSC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2010
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2010
CompletedFirst Posted
Study publicly available on registry
June 11, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
April 23, 2013
CompletedFebruary 6, 2018
February 1, 2018
2.2 years
June 10, 2010
March 12, 2013
February 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Serum Alkaline Phosphatase
Serum alkaline phosphatase will be measured at entry and end of study
6 months
Secondary Outcomes (1)
Mayo Risk Score for Primary Sclerosing Cholangitis
6 months
Study Arms (1)
Fenofibrate
EXPERIMENTALfenofibrate 160 mg po daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- University of Floridacollaborator
Study Sites (2)
University of Florida
Gainesville, Florida, 32608, United States
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Cynthia Levy
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia Levy, MD
University of Miami
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Clinical
Study Record Dates
First Submitted
June 10, 2010
First Posted
June 11, 2010
Study Start
October 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
February 6, 2018
Results First Posted
April 23, 2013
Record last verified: 2018-02