Pilot Study of Fenofibrate for PSC
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|ClinicalTrials.gov Identifier: NCT01142323|
Recruitment Status : Terminated
First Posted : June 11, 2010
Results First Posted : April 23, 2013
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Primary Sclerosing Cholangitis||Drug: fenofibrate||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Fenofibrate in Primary Sclerosing Cholangitis|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
fenofibrate 160 mg po daily
160 mg po daily
- Serum Alkaline Phosphatase [ Time Frame: 6 months ]Serum alkaline phosphatase will be measured at entry and end of study
- Mayo Risk Score for Primary Sclerosing Cholangitis [ Time Frame: 6 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142323
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32608|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Cynthia Levy, MD||University of Miami|