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Trial record 46 of 92 for:    Primary Sclerosing Cholangitis

Pilot Study of Fenofibrate for PSC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01142323
Recruitment Status : Terminated
First Posted : June 11, 2010
Results First Posted : April 23, 2013
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
Cynthia Levy, University of Miami

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Sclerosing Cholangitis
Intervention Drug: fenofibrate
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fenofibrate
Hide Arm/Group Description fenofibrate 160 mg po daily
Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Fenofibrate
Hide Arm/Group Description fenofibrate 160 mg po daily
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
43.7  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
2
  25.0%
Male
6
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Serum Alkaline Phosphatase
Hide Description Serum alkaline phosphatase will be measured at entry and end of study
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline At 6 Months
Hide Arm/Group Description:
Prior to drug intervention
fenofibrate 160 mg/day
Overall Number of Participants Analyzed 8 8
Median (Standard Error)
Unit of Measure: U/L
290  (76) 165  (19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Baseline, At 6 Months
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Matched pairs
Comments [Not Specified]
2.Secondary Outcome
Title Mayo Risk Score for Primary Sclerosing Cholangitis
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Median baseline MRS was compared to Median MRS after 6 months of study drug
Arm/Group Title Fenofibrate
Hide Arm/Group Description:

fenofibrate 160 mg po daily

fenofibrate: 160 mg po daily

Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: score
Baseline
-0.41
(-0.71 to 1.4)
After 6 months
-0.46
(-0.96 to 1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fenofibrate
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fenofibrate
Hide Arm/Group Description fenofibrate 160 mg po daily
All-Cause Mortality
Fenofibrate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fenofibrate
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fenofibrate
Affected / at Risk (%) # Events
Total   1/8 (12.50%)    
Skin and subcutaneous tissue disorders   
worsening of psoriasis * [1]  1/1 (100.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Only 1 patient had psoriasis at baseline, and therefore only 1 patient was at risk for worsening of Psoriasis. Of note, none of the other 7 patients developed new psoriasis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Cynthia Levy
Organization: University of Miami
Phone: 305-243-2147
EMail: clevy@med.miami.edu
Layout table for additonal information
Responsible Party: Cynthia Levy, University of Miami
ClinicalTrials.gov Identifier: NCT01142323     History of Changes
Other Study ID Numbers: 20100533
First Submitted: June 10, 2010
First Posted: June 11, 2010
Results First Submitted: March 12, 2013
Results First Posted: April 23, 2013
Last Update Posted: February 6, 2018