Clinical Trial: Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Multi-center, Open-label, Uncontrolled Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions

Brief Summary: To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24 months or less with immunocompromised medical conditions.

Detailed Summary:
Sponsor: AbbVie (prior sponsor, Abbott)

Current Primary Outcome: Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121 [ Time Frame: Day 1 (Screening), Day 31, Day 121 ]

Original Primary Outcome: Serum trough palivizumab level [ Time Frame: 30 days after the first and the fourth administrations of palivizumab ]

Current Secondary Outcome:

• Percentage of Participants Requiring Hospitalization For Respiratory Syncytial Virus (RSV) Infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days. ]
• Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days. ]
  Percentage of participants who required any of the investigated treatments (admission in the intensive care unit [ICU], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.
• Duration of Hospitalization Caused by Respiratory Syncytial Virus (RSV) Infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days. ]
  Number of days of hospitalization caused by RSV infection.
• Duration of Required Treatment for Respiratory Syncytial Virus (RSV) Infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days. ]
  Duration (days) of requirement for any of the investigated treatments (admission in the intensive care unit [ICU], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.
• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs [ Time Frame: From the first administration of palivizumab to 100 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days. ]
  An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.
• Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121 [ Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose) ]
• Mean Baseline and Mean Change From Baseline in Body Temperature at Day 121 [ Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose) ]
• Mean Baseline and Mean Change From Baseline in Respiratory Rate at Day 121 [ Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose) ]
• Mean Baseline and Mean Change From Baseline in Pulse Rate at Day 121 [ Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose) ]
• Mean Baseline and Mean Change From Baseline in Body Weight at Day 121 [ Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose) ]
• Hematology: Mean Baseline and Mean Change From Baseline in Hemoglobin at Day 121 [ Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose) ]
  Normal range for hemoglobin varied by the monthly age of the participant.
• Hematology: Mean Baseline and Mean Change From Baseline in Hematocrit at Day 121 [ Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose) ]
  Normal range for hematocrit varied by the monthly age of the participant.
• Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121 [ Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose) ]
  Normal ranges for WBC, neutrophils, eosinophils, basophils, lymphocytes, and monocytes varied by the monthly age of the participant.
• Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121 [ Time Frame: Baseline (Day 1), Day 121 (30 days after the 4th dose) ]
  Normal ranges for RBC and platelet count varied by the monthly age of the participant.
• Blood Chemistry: Mean Baseline and Cha
  
  

  Original Secondary Outcome:

  • Hospitalization caused by respiratory syncytial virus (RSV) infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab ]
    Number and percentage of subjects with hospitalization caused by RSV infection and 95% confidence interval for percentage
  • Requirement for oxygen supplementation caused by RSV infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab ]
    Number and percentage of subjects with requirement of oxygen inhalation caused by RSV infection and 95% confidence interval for percentage
  • Requirement for mechanical ventilation caused by RSV infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab ]
    Number and percentage of subjects with requirement of mechanical ventilation caused by RSV infection and 95% confidence interval for percentage
  • Requirement for extracorporeal membrane oxygenation caused by RSV infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab ]
    Number and percentage of subjects with requirement of extracorporeal membrane oxygenation caused by RSV infection and 95% confidence interval for percentage
  • Requirement for continuous positive airway pressure caused by RSV infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab ]
    Number and percentage of subjects with requirement of continuous positive airway pressure caused by RSV infection and 95% confidence interval for percentage
  • Requirement for other mechanical respiratory support caused by RSV infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab ]
    Number and percentage of subjects with requirement of other mechanical respiratory support caused by RSV infection and 95% confidence interval for percentage
  • Requirement for Intensive Care Unit (ICU) admission caused by RSV infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab ]
    Number and percentage of subjects with requirement of ICU admission caused by RSV infection and 95% confidence interval for percentage
  • Duration of hospitalization caused by RSV infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab ]
    Duration (days) of hospitalization caused by RSV infection: mean, standard deviation, 95% confidence interval, median and range
  • Duration of requirement for oxygen supplementation caused by RSV infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab ]
    Duration (days) of requirement for oxygen supplementation caused by RSV infection:mean, standard deviation, 95% confidence interval, median and range
  • Duration of requirement for mechanical ventilation caused by RSV infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab ]
    Duration (days) of requirement for mechanical ventilation caused by RSV infection: mean, standard deviation, 95% confidence interval, median and range
  • Duration of requirement for extracorporeal membrane oxygenation caused by RSV infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab ]
    Duration (days) of requirement for extracorporeal membrane oxygenation caused by RSV infection: mean, standard deviation, 95% confidence interval, median and range
  • Duration of requirement for continuous positive airway pressure caused by RSV infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab ]
    Duration (days) of requirement for continuous positive airway pressure caused by RSV infection: mean, standard deviation, 95% confidence interval, median and range
  • Duration of requirement for other mechanical respiratory support caused by RSV infection [ Time Frame: From the first administration of palivizumab to 30 days after the last administration of palivizumab ]
    Duration (days) of requirement for other mechanical respiratory support caused by RSV infection : mean, standard deviation, 95% confidence interval, median and range
  • Duration of requirement for ICU admission caused by RSV infection [ Time Frame: From the first administration of palivizumab to 30 days
    
    Information By: AbbVie
    

    Dates:
    Date Received: September 12, 2011
    Date Started: August 2011
    Date Completion:
    Last Updated: June 13, 2013
    Last Verified: June 2013