Surveillance of Synagis in Korean Pediatric Patients

Completed

• Conditions: Respiratory Syncytial Virus Infection

• Registration Number: NCT01537198
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

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 Description

Not available

Study Timeline

• Study First Submitted: 2011-12-15
• Study Start: 2012-01
• Study First Submitted QC: 2012-02-17
• Study First Posted: 2012-02-23
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-06
• Results First Submitted: 2015-06-18
• Results First Submitted QC: 2015-06-18
• Last Update Submitted: 2015-06-18
• Results First Posted: 2015-07-10
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 618

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)	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.