Surveillance of Synagis in Korean Pediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01537198
First received: December 15, 2011
Last updated: June 18, 2015
Last verified: June 2015

December 15, 2011
June 18, 2015
January 2012
June 2014   (final data collection date for primary outcome measure)
Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs) [ Time Frame: From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis ] [ Designated as safety issue: Yes ]
An AE was defined as any untoward medical occurrence that did not necessarily have a causal relationship with treatment. An SAE was an event that resulted in death, was life-threatening, required or prolonged hospitalization, resulted in congenital anomaly or persistent or significant disability, important medical event requiring medical or surgical intervention to prevent serious outcome, or a spontaneous or elective abortion. AEs considered to be related to Synagis were classified as ADRs. The causality of ADRs were assessed by the investigator as 'Probable,' 'Possible' and 'others (unknown). 'Unexpected' AEs are those that are unlabeled.
  • Number of Subjects with Adverse Events [ Time Frame: Participants will be observed to 30 days after the final administration of Synagis, an expected average of 6 months ] [ Designated as safety issue: Yes ]
  • Body Weight [ Time Frame: Participants will be observed to 30 days after the final administration of Synagis, an expected average of 6 months ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: Participants will be observed to 30 days after the final administration of Synagis, an expected average of 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01537198 on ClinicalTrials.gov Archive Site
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Surveillance of Synagis in Korean Pediatric Patients
Post-Marketing Surveillance of Synagis in Korean Pediatric Patients Under the "New Drug Re-Examination"
Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, gestational age, birth weight and underlying diseases and complications especially in regard to respiratory disease and cardiovascular disease. At routine visits for Synagis administration, which will occur according to usual medical practice, information on Synagis prophylaxis, concomitant medication, and adverse events will be collected for up to 30 days after the last administration of Synagis.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
General hospital
Respiratory Syncytial Virus Infection
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Pediatric Participants at High Risk of RSV
Pediatric participants at high risk of respiratory syncytial virus (RSV) in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant's enrollment in the study.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
618
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pediatric patients at high risk of RSV disease, who need the prevention of serious lower respiratory tract disease caused by RSV, and meet any of the following criteria:

    • Preterm newborn infants or infants born at 35 weeks of gestation or less, and less than 6 months of age at the onset of RSV season (RSV season defined as Oct. 1 to the following Mar. 31).
    • Newborn infants, infants, or children under 2 years of age and requiring treatment for bronchopulmonary dysplasia (BPD) within the last 6 months preceding RSV season (RSV season defined as Oct. 1 to the following Mar. 31).
    • Newborn infants, infants, or children under 2 years of age with hemodynamically significant congenital heart disease (CHD).
  • Obtained authorization form to use personal and/or health data from legal representative prior to the entry into the study.

Exclusion Criteria:

  • Contraindications according to the approved label.
Both
up to 24 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
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Korea, Republic of
 
NCT01537198
P13-203
No
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AbbVie (prior sponsor, Abbott)
AbbVie (prior sponsor, Abbott)
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Study Director: SoRa Lee, MD AbbVie
AbbVie
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP