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De Novo Sirolimus-based Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norman Kneteman, University of Alberta
ClinicalTrials.gov Identifier:
NCT00328770
First received: May 19, 2006
Last updated: August 27, 2012
Last verified: August 2012
History of Changes
Results First Received: June 12, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Liver Carcinoma
Intervention: Drug: Sirolimus

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All adults receiving a liver transplant between December 1996 and March 2006 who had hepatocellular carcinoma and were treated with sirolimus as part of their immunosuppression after their transplant were included in this trial.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Study Patients All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation

Participant Flow:   Overall Study
    All Study Patients  
STARTED     70  
COMPLETED     70  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
All Study Patients All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation

Baseline Measures
    All Study Patients  
Number of Participants  
[units: participants]
 		  70  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     70  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  54.6  ± 7.3  
Gender  
[units: participants]
 		 
Female     12  
Male     58  
Region of Enrollment  
[units: participants]
 		 
Canada     70  



  Outcome Measures
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1.  Primary:   Percentage of Participants Surviving at One and Four Years After Liver Transplant   [ Time Frame: 1 & 4 years ]
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2.  Primary:   Percentage of Participants Surviving With no Evidence of Recurrent Tumor at One and Four Years After Liver Transplant   [ Time Frame: 1 and 4 years ]
  Show Outcome Measure 2

3.  Secondary:   Sirolimus Toxicity/Intolerance   [ Time Frame: 1 year ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Dr. Norman Kneteman
Organization: Liver Transplant Program, University of Alberta Hospitals
phone: 780-407-6168
e-mail: norm.kneteman@albertahealthservices.ca


No publications provided by University of Alberta

Publications automatically indexed to this study:


Responsible Party: Norman Kneteman, University of Alberta
ClinicalTrials.gov Identifier: NCT00328770     History of Changes
Other Study ID Numbers: #4279
Study First Received: May 19, 2006
Results First Received: June 12, 2012
Last Updated: August 27, 2012
Health Authority: Canada: Health Canada