NCT01537198

Surveillance of Synagis in Korean Pediatric Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 618 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 1 Day – 24 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Syncytial Virus Infection

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-02-23
• Last updated: 2015-07-10
• Results posted: 2015-07-10