Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00149890
First received: September 6, 2005
Last updated: August 17, 2011
Last verified: August 2011
Results First Received: January 20, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Liver Transplantation
Infection
Interventions: Drug: Basiliximab
Drug: Cyclosporine/cyclosporine microemulsion
Drug: Steroid

  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
With Intraoperative Steroids Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
Without Intraoperative Steroids No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.

Participant Flow:   Overall Study
    With Intraoperative Steroids     Without Intraoperative Steroids  
STARTED     39 [1]   38  
COMPLETED     26     20  
NOT COMPLETED     13     18  
Adverse Event                 1                 8  
Lack of Efficacy                 8                 9  
Protocol Violation                 1                 0  
Lost to Follow-up                 1                 0  
Graft Loss                 2                 1  
[1] "Started" indicates all screened and treated participants.



  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.
No text entered.

Reporting Groups
  Description
With Intraoperative Steroids Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
Without Intraoperative Steroids No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
Total Total of all reporting groups

Baseline Measures
    With Intraoperative Steroids     Without Intraoperative Steroids     Total  
Number of Participants  
[units: participants]
  39     38     77  
Age  
[units: years]
Mean ± Standard Deviation
  3.08  ± 4.09     3.71  ± 5.36     3.39  ± 4.74  
Age, Customized  
[units: participants]
     
<2 years     21     24     45  
from 2 to 16 years     18     14     32  
Gender  
[units: participants]
     
Female     21     19     40  
Male     18     19     37  



  Outcome Measures
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1.  Primary:   Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation   [ Time Frame: 3 months after treatment ]

2.  Secondary:   Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months   [ Time Frame: 3 months ]

3.  Secondary:   Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months   [ Time Frame: 3 and 6 months ]

4.  Secondary:   Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation   [ Time Frame: 3 months and 6 months ]

5.  Secondary:   Number of Participants With Bacterial, Viral and Fungal Infections During Six Months   [ Time Frame: 6 months ]

6.  Secondary:   Time of Onset of a First Biopsy Proven Acute Rejection   [ Time Frame: 6 months ]

7.  Secondary:   Percentage of Participants With Treatment Failure Within Three and Six Months   [ Time Frame: 3 and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00149890     History of Changes
Other Study ID Numbers: CCHI621ADE04
Study First Received: September 6, 2005
Results First Received: January 20, 2011
Last Updated: August 17, 2011
Health Authority: Germany: Paul-Ehrlich-Institut