Clinical Trial: Surveillance of Synagis in Korean Pediatric Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Post-Marketing Surveillance of Synagis in Korean Pediatric Patients Under the "New Drug Re-Examination"

Brief Summary: 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.

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

Current Primary Outcome: 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 ]

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.


Original Primary Outcome:

  • 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 ]
  • Body Weight [ Time Frame: Participants will be observed to 30 days after the final administration of Synagis, an expected average of 6 months ]
  • Vital Signs [ Time Frame: Participants will be observed to 30 days after the final administration of Synagis, an expected average of 6 months ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: AbbVie

Dates:
Date Received: December 15, 2011
Date Started: January 2012
Date Completion:
Last Updated: June 18, 2015
Last Verified: June 2015