Surveillance of Synagis in Korean Pediatric Patients
This study is enrolling participants by invitation only.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01537198
First received: December 15, 2011
Last updated: March 18, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Approximately 600 pediatric patients prescribed 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, the information on Synagis prophylaxis, concomitant medication information and adverse events information will be collected for up to 30 days after the last administration of Synagis.
| Condition |
|---|
|
Respiratory Syncytial Virus Infection |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Post-Marketing Surveillance of Synagis in Korean Pediatric Patients Under the New Drug Re-Examination |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | February 2017 |
| Estimated Primary Completion Date: | February 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Pediatric patients at high risk of Respiratory Syncytial Virus
Pediatric patients at high risk of RSV, who need the prevention of serious lower respiratory tract disease caused by RSV
|
Eligibility| Ages Eligible for Study: | up to 24 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
General hospital
Criteria
Inclusion Criteria:
Pediatric patients at high risk of respiratory syncytial virus (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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537198
Locations
| Korea, Republic of | |
| Site Reference ID/Investigator# 64867 | |
| Ansan-si, Korea, Republic of | |
| Site Reference ID/Investigator# 64856 | |
| Bucheon-si, Korea, Republic of | |
| Site Reference ID/Investigator# 64859 | |
| Busan, Korea, Republic of | |
| Site Reference ID/Investigator# 64858 | |
| Busan, Korea, Republic of | |
| Site Reference ID/Investigator# 64860 | |
| Busan, Korea, Republic of, 602-702 | |
| Site Reference ID/Investigator# 64888 | |
| Busan, Korea, Republic of | |
| Site Reference ID/Investigator# 64886 | |
| Busan, Korea, Republic of, 614-735 | |
| Site Reference ID/Investigator# 64874 | |
| Chungcheongbuk-do, Korea, Republic of, 361-711 | |
| Site Reference ID/Investigator# 64846 | |
| Daegu, Korea, Republic of, 700-712 | |
| Site Reference ID/Investigator# 64868 | |
| Daegu, Korea, Republic of, 705-718 | |
| Site Reference ID/Investigator# 64875 | |
| Daegu, Korea, Republic of | |
| Site Reference ID/Investigator# 64873 | |
| Daejeon, Korea, Republic of | |
| Site Reference ID/Investigator# 64852 | |
| Gwangju, Korea, Republic of | |
| Site Reference ID/Investigator# 64871 | |
| Gwangju, Korea, Republic of | |
| Site Reference ID/Investigator# 64857 | |
| Incheon, Korea, Republic of | |
| Site Reference ID/Investigator# 64851 | |
| Seoul, Korea, Republic of | |
| Site Reference ID/Investigator# 64850 | |
| Seoul, Korea, Republic of | |
| Site Reference ID/Investigator# 64842 | |
| Seoul, Korea, Republic of | |
| Site Reference ID/Investigator# 64853 | |
| Seoul, Korea, Republic of | |
| Site Reference ID/Investigator# 64870 | |
| Seoul, Korea, Republic of | |
| Site Reference ID/Investigator# 64854 | |
| Seoul, Korea, Republic of | |
| Site Reference ID/Investigator# 64872 | |
| Seoul, Korea, Republic of | |
| Site Reference ID/Investigator# 64855 | |
| Seoul, Korea, Republic of | |
| Site Reference ID/Investigator# 64849 | |
| Seoul, Korea, Republic of, 110-744 | |
| Site Reference ID/Investigator# 64863 | |
| Seoul, Korea, Republic of, 135-710 | |
| Site Reference ID/Investigator# 64864 | |
| Seoul, Korea, Republic of, 135-710 | |
| Site Reference ID/Investigator# 64883 | |
| Seoul, Korea, Republic of, 138-736 | |
| Site Reference ID/Investigator# 64882 | |
| Seoul, Korea, Republic of, 133-792 | |
| Site Reference ID/Investigator# 64884 | |
| Seoul, Korea, Republic of, 138-736 | |
| Site Reference ID/Investigator# 64887 | |
| Seoul, Korea, Republic of | |
| Site Reference ID/Investigator# 64877 | |
| Sungnam-si, Korea, Republic of | |
| Site Reference ID/Investigator# 64866 | |
| Suwon-si, Korea, Republic of, 443-721 | |
| Site Reference ID/Investigator# 64865 | |
| Suwon-si, Korea, Republic of, 443-721 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Deborah Chee, MD | AbbVie |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01537198 History of Changes |
| Other Study ID Numbers: | P13-203 |
| Study First Received: | December 15, 2011 |
| Last Updated: | March 18, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by AbbVie:
|
Postmarketing Drug Surveillance |
Additional relevant MeSH terms:
|
Respiratory Syncytial Virus Infections Virus Diseases Pneumovirus Infections |
Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections |
ClinicalTrials.gov processed this record on May 16, 2013