A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00332462
First received: May 30, 2006
Last updated: March 1, 2011
Last verified: March 2011
Results First Received: December 13, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Liver Transplantation
Interventions: Drug: Cyclosporine (Sandimmun® i.v.)
Drug: Cyclosporine (Sandimmun® Optoral)

  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
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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
Cyclosporine (Sandimmun®) Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.

Participant Flow:   Overall Study
    Cyclosporine (Sandimmun®)  
STARTED     34 [1]
Patients Treated With Sandimmun® i.v.     34  
Patients Treated With Sandimmun® Optoral     29  
COMPLETED     18  
NOT COMPLETED     16  
Adverse Event                 5  
Abnormal Lab Value                 1  
Unsatisfactory therapeutic effect                 4  
no longer requires study drug                 1  
Death                 3  
Graft Loss                 2  
[1] Safety and Intention to treat population.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Cyclosporine (Sandimmun®) Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.

Baseline Measures
    Cyclosporine (Sandimmun®)  
Number of Participants  
[units: participants]
  34  
Age  
[units: years]
Mean ± Standard Deviation
  53.2  ± 9.6  
Gender  
[units: participants]
 
Female     12  
Male     22  



  Outcome Measures
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1.  Primary:   Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation   [ Time Frame: 3 months ]

2.  Secondary:   Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation   [ Time Frame: 3 or 6 months after transplantation ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00332462     History of Changes
Other Study ID Numbers: COLO400ADE01
Study First Received: May 30, 2006
Results First Received: December 13, 2010
Last Updated: March 1, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices