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A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00538785
First received: October 1, 2007
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
Results First Received: January 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Congenital Heart Disease
Interventions: Biological: Motavizumab
Biological: Palivizumab

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
Motavizumab (MEDI-524) Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Palivizumab Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
Total Total of all reporting groups

Baseline Measures
    Motavizumab (MEDI-524)     Palivizumab     Total  
Number of Participants  
[units: participants]
 		  623     612     1235  
Age  
[units: months]
Mean ± Standard Deviation 		  8.47  ± 6.40     8.18  ± 6.51     8.33  ± 6.45  
Gender  
[units: participants]
 		     
Female     282     298     580  
Male     341     314     655  
Race/Ethnicity, Customized  
[units: participants]
 		     
White/Non-hispanic     540     529     1069  
Black     23     20     43  
Hispanic     21     23     44  
Asian     10     8     18  
Other     29     32     61  
Region of Enrollment  
[units: participants]
 		     
United States     155     146     301  
Spain     31     26     57  
Lebanon     62     66     128  
Austria     7     7     14  
Israel     67     65     132  
Russian Federation     32     34     66  
United Kingdom     26     31     57  
France     13     15     28  
Czech Republic     35     39     74  
Hungary     27     26     53  
Canada     27     22     49  
Belgium     28     26     54  
Poland     50     49     99  
Bulgaria     18     18     36  
Germany     35     31     66  
Sweden     10     11     21  



  Outcome Measures
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1.  Primary:   Number of Subjects Reporting Adverse Events Through Study Day 150   [ Time Frame: Days 0-150 ]
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2.  Primary:   Number of Subjects Reporting Serious Adverse Events Through Study Day 150   [ Time Frame: Days 0-150 ]
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3.  Primary:   Number of Subjects Reporting Laboratory Adverse Events   [ Time Frame: Days 0-150 ]
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4.  Secondary:   The Number of Subjects Hospitalized for RSV Infection.   [ Time Frame: Days 0-150 ]
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5.  Secondary:   The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only.   [ Time Frame: Days 0-150 ]
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6.  Secondary:   Number of Subjects Who Had Anti-motavizumab Antibodies Detected   [ Time Frame: Days 0-150 ]
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7.  Secondary:   Mean Trough Serum Concentration of Motavizumab at Pre-dose 1   [ Time Frame: Pre-dose 1 ]
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8.  Secondary:   Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1   [ Time Frame: 30 days post-dose 1 ]
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9.  Secondary:   Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2   [ Time Frame: 30 days post-dose 2 ]
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10.  Secondary:   Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3   [ Time Frame: 30 days post-dose 3 ]
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11.  Secondary:   Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4   [ Time Frame: 30 days post-dose 4 ]
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12.  Secondary:   Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery With Cardiopulmonary Bypass   [ Time Frame: Days 0-150 ]
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  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 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
No text entered.  


Results Point of Contact:  
Name/Title: Pamela Griffin, Senior Director, Clinical Development
Organization: MedImmune, LLC
phone: 301 398 0000
e-mail: griffinp@medimmune.com


No publications provided


Responsible Party: Pamela Griffin, Senior Director, Clinical Development, MedImmune, LLC
ClinicalTrials.gov Identifier: NCT00538785     History of Changes
Obsolete Identifiers: NCT00240890
Other Study ID Numbers: MI-CP124-S2
Study First Received: October 1, 2007
Results First Received: January 11, 2012
Last Updated: February 14, 2012
Health Authority: United States: Food and Drug Administration