Trial Outcomes & Findings for Study of Sirolimus Versus Mycophenolate Liver Transplant Recipients With Recurrent Hepatitis C Virus (HCV) (NCT NCT01134952)

NCT ID: NCT01134952

Last Updated: 2015-02-26

Results Overview

Percent change in HCV load determined 3 months after switch from MMF to SRL.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 11 participants
• Primary outcome timeframe: 3 month
• Results posted on: 2015-02-26

Participant Flow

Participant milestones

Measure	MMF SRL Switch Liver transplant recipients with Hepatitis C virus taking sirolimus (SRL) instead of mycophenolate mofetil (MMF) for 3 months
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	MMF MRL Switch n=11 Participants Liver transplant recipients with Hepatitis C virus switched from mycophenolate mofetil (MMF) to sirolimus (SRL) for 3 months and then switched back to MMF
Age, Continuous	53 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment Canada	11 participants n=5 Participants
Hepatitis C viral load	2.8 10^7 HCV IU/mL STANDARD_DEVIATION 2.6 • n=5 Participants
Tacrolimus trough level	5.5 ng/ml STANDARD_DEVIATION 1.9 • n=5 Participants
Bilirubin	8.8 umol/L STANDARD_DEVIATION 3.2 • n=5 Participants
Alkaline phosphatase	94.5 U/L STANDARD_DEVIATION 40.2 • n=5 Participants
Alanine aminotransferase	86.3 U/ml STANDARD_DEVIATION 56.1 • n=5 Participants
Hemoglobin	145.1 g/L STANDARD_DEVIATION 13.2 • n=5 Participants
Platelet count	165.3 10^9/L STANDARD_DEVIATION 58.3 • n=5 Participants
Fasting cholesterol	4.9 mmol/L STANDARD_DEVIATION 1.4 • n=5 Participants
Triglyceride	1.7 mmol/L STANDARD_DEVIATION 0.5 • n=5 Participants

PRIMARY outcome

Timeframe: 3 month

Percent change in HCV load determined 3 months after switch from MMF to SRL.

Outcome measures

Measure	MMF SRL Switch n=11 Participants Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
Delta Hepatitis C Viral Load	15 percent change Standard Deviation 53

SECONDARY outcome

Timeframe: 3 month

Percent change in HCV load determined 3 months after switch from SRL to MMF

Outcome measures

Measure	MMF SRL Switch n=11 Participants Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
Final Hepatitis C Viral Load	-47 percent change Standard Deviation 100

SECONDARY outcome

Timeframe: 3 month

Outcome measures

Measure	MMF SRL Switch n=11 Participants Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
Sirolimus Trough Level	7.2 ng/ml Standard Deviation 2.2

SECONDARY outcome

Timeframe: 3 month

Population: 2 patients did not have tacrolimus levels recorded during both time periods and are excluded

Percent change determined 3 months after switch from MMF to SRL

Outcome measures

Measure	MMF SRL Switch n=9 Participants Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
Delta Tacrolimus Trough Level	23 percent change Standard Deviation 82

SECONDARY outcome

Timeframe: 3 month

Population: Levels available at correct time in only 7 patients

Percent change determined 3 months after switch from MMF to SRL

Outcome measures

Measure	MMF SRL Switch n=7 Participants Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
Delta Bilirubin	-6.0 percent change Standard Deviation 25

SECONDARY outcome

Timeframe: 3 month

Population: Levels not available at appropriate times in 2 patients

Percent change determined 3 months after switch from MMF to SRL

Outcome measures

Measure	MMF SRL Switch n=9 Participants Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
Delta Alkaline Phosphatase	13.8 percent change Standard Deviation 3

SECONDARY outcome

Timeframe: 3 month

Population: Levels at appropriate time not available in 2 patients

Percent change determined 3 months after switch from MMF to SRL

Outcome measures

Measure	MMF SRL Switch n=9 Participants Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
Delta Alanine Aminotransferase	9 percent change Standard Deviation 28

SECONDARY outcome

Timeframe: 3 month

Population: Levels at appropriate times not available in 2 patients

Percent change determined 3 months after switch from MMF to SRL

Outcome measures

Measure	MMF SRL Switch n=9 Participants Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
Delta Hemoglobin	-2.7 percent change Standard Deviation 2.7

SECONDARY outcome

Timeframe: 3 month

Population: Levels not available on 2 patients at appropriate time

Percent change determined 3 months after switch from MMF to SRL

Outcome measures

Measure	MMF SRL Switch n=9 Participants Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
Delta Platelet Count	-8.5 percent change Standard Deviation 20

SECONDARY outcome

Timeframe: 3 month

Population: Levels not available for 2 patients

Percent change determined 3 months after switch from MMF to SRL

Outcome measures

Measure	MMF SRL Switch n=9 Participants Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
Delta Cholesterol Fasting Level	1.2 percent change Standard Deviation 55

SECONDARY outcome

Timeframe: 3 month

Population: Levels at appropriate times not available on 2 patients

Percent change determined 3 months after switch from MMF to SRL

Outcome measures

Measure	MMF SRL Switch n=9 Participants Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
Delta Triglyceride Fasting Level	23 percent change Standard Deviation 81

Adverse Events

MMF SRL Switch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Vivian McAlister

LondonHSC

Phone: 5196632920

Email: vmcalist@uwo.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place