Pilot Study of Fenofibrate for PSC
|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|
|Primary Completion Date :||December 2012|
|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.
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|