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Trial record 9 of 36 for:    "Viral Infectious Disease" | "Everolimus"

Study of Sirolimus Versus Mycophenolate Liver Transplant Recipients With Recurrent Hepatitis C Virus (HCV)

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ClinicalTrials.gov Identifier: NCT01134952
Recruitment Status : Completed
First Posted : June 2, 2010
Results First Posted : January 21, 2015
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
Vivian McAlister, London Health Sciences Centre

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Hepatitis C
Intervention Drug: Mycophenolate to sirolimus switch
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MMF SRL Switch
Hide Arm/Group Description Liver transplant recipients with Hepatitis C virus taking sirolimus (SRL) instead of mycophenolate mofetil (MMF) for 3 months
Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title MMF MRL Switch
Hide Arm/Group Description Liver transplant recipients with Hepatitis C virus switched from mycophenolate mofetil (MMF) to sirolimus (SRL) for 3 months and then switched back to MMF
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
53  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
3
  27.3%
Male
8
  72.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 11 participants
11
Hepatitis C viral load  
Mean (Standard Deviation)
Unit of measure:  10^7 HCV IU/mL
Number Analyzed 11 participants
2.8  (2.6)
Tacrolimus trough level  
Mean (Standard Deviation)
Unit of measure:  Ng/ml
Number Analyzed 11 participants
5.5  (1.9)
Bilirubin  
Mean (Standard Deviation)
Unit of measure:  umol/L
Number Analyzed 11 participants
8.8  (3.2)
Alkaline phosphatase  
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 11 participants
94.5  (40.2)
Alanine aminotransferase  
Mean (Standard Deviation)
Unit of measure:  U/ml
Number Analyzed 11 participants
86.3  (56.1)
Hemoglobin  
Mean (Standard Deviation)
Unit of measure:  g/L
Number Analyzed 11 participants
145.1  (13.2)
Platelet count  
Mean (Standard Deviation)
Unit of measure:  10^9/L
Number Analyzed 11 participants
165.3  (58.3)
Fasting cholesterol  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 11 participants
4.9  (1.4)
Triglyceride  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 11 participants
1.7  (0.5)
1.Primary Outcome
Title Delta Hepatitis C Viral Load
Hide Description Percent change in HCV load determined 3 months after switch from MMF to SRL.
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MMF SRL Switch
Hide Arm/Group Description:
Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: percent change
15  (53)
2.Secondary Outcome
Title Final Hepatitis C Viral Load
Hide Description Percent change in HCV load determined 3 months after switch from SRL to MMF
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MMF SRL Switch
Hide Arm/Group Description:
All patients switched for 3 months from mycophenolate mofetil to sirolimus and then back to mycophenolate mofetil
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: percent change
-47  (100)
3.Secondary Outcome
Title Sirolimus Trough Level
Hide Description [Not Specified]
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MMF SRL Switch
Hide Arm/Group Description:
All patients after switch from mycophenolate to sirolimus
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: ng/ml
7.2  (2.2)
4.Secondary Outcome
Title Delta Tacrolimus Trough Level
Hide Description Percent change determined 3 months after switch from MMF to SRL
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients did not have tacrolimus levels recorded during both time periods and are excluded
Arm/Group Title MMF SRL Switch
Hide Arm/Group Description:
Liver transplant recipients switched from mycophenolate mofetil to sirolimus
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: percent change
23  (82)
5.Secondary Outcome
Title Delta Bilirubin
Hide Description Percent change determined 3 months after switch from MMF to SRL
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
Levels available at correct time in only 7 patients
Arm/Group Title MMF SRL Switch
Hide Arm/Group Description:
All patients 3 months after switch from mycophenolate to sirolimus
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: percent change
-6.0  (25)
6.Secondary Outcome
Title Delta Alkaline Phosphatase
Hide Description Percent change determined 3 months after switch from MMF to SRL
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
Levels not available at appropriate times in 2 patients
Arm/Group Title MMF SRL Switch
Hide Arm/Group Description:
All patients 3 months after switch from mycophenolate to sirolimus
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: percent change
13.8  (3)
7.Secondary Outcome
Title Delta Alanine Aminotransferase
Hide Description Percent change determined 3 months after switch from MMF to SRL
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
Levels at appropriate time not available in 2 patients
Arm/Group Title MMF SRL Switch
Hide Arm/Group Description:
All patients 3 months after switch from mycophenolate to sirolimus
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: percent change
9  (28)
8.Secondary Outcome
Title Delta Hemoglobin
Hide Description Percent change determined 3 months after switch from MMF to SRL
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
Levels at appropriate times not available in 2 patients
Arm/Group Title MMF SRL Switch
Hide Arm/Group Description:
All patients 3 months after switch from mycophenolate to sirolimus
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: percent change
-2.7  (2.7)
9.Secondary Outcome
Title Delta Platelet Count
Hide Description Percent change determined 3 months after switch from MMF to SRL
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
Levels not available on 2 patients at appropriate time
Arm/Group Title MMF SRL Switch
Hide Arm/Group Description:
All patients 3 months after switch from mycophenolate to sirolimus
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: percent change
-8.5  (20)
10.Secondary Outcome
Title Delta Cholesterol Fasting Level
Hide Description Percent change determined 3 months after switch from MMF to SRL
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
Levels not available for 2 patients
Arm/Group Title MMF SRL Switch
Hide Arm/Group Description:
All patients 3 months after switch from mycophenolate to sirolimus
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: percent change
1.2  (55)
11.Secondary Outcome
Title Delta Triglyceride Fasting Level
Hide Description Percent change determined 3 months after switch from MMF to SRL
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
Levels at appropriate times not available on 2 patients
Arm/Group Title MMF SRL Switch
Hide Arm/Group Description:
All patients 3 months after switch from mycophenolate to sirolimus
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: percent change
23  (81)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MMF SRL Switch
Hide Arm/Group Description All patients during 3 month period of switch from mycophenolate mofetil (MMF) to sirolimus and for 3 months after switch back to MMF
All-Cause Mortality
MMF SRL Switch
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MMF SRL Switch
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MMF SRL Switch
Affected / at Risk (%)
Total   0/11 (0.00%) 
Greater than expected baseline variation; technical problems with laboratory measurement of HCV (two different platforms used); and poor recruitment over a long period make the results difficult to interpret.
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 Vivian McAlister
Organization: LondonHSC
Phone: 5196632920
EMail: vmcalist@uwo.ca
Publications:
Layout table for additonal information
Responsible Party: Vivian McAlister, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01134952     History of Changes
Other Study ID Numbers: UWO12961
First Submitted: May 27, 2010
First Posted: June 2, 2010
Results First Submitted: December 15, 2014
Results First Posted: January 21, 2015
Last Update Posted: February 26, 2015