Status:
COMPLETED
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
Up to 24 years
Brief Summary
The SYNAGIS Registry was carried out in order to gather comprehensive real-world data on the use of palivizumab in children at high risk for serious respiratory syncytial virus (RSV) disease. This reg...
Detailed Description
Each participant included in this study was observed during his/her palivizumab prophylaxis during the prevailing RSV season. According to the requirements for non-interventional or observational stud...
Eligibility Criteria
Inclusion
- Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the Respiratory syncytial virus season
- Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.
- Children less than 2 years of age and with hemodynamically significant congenital heart disease.
Exclusion
- Children with known hypersensitivity to palivizumab or any component of the formulation, or other humanized monoclonal antibodies
Key Trial Info
Start Date :
September 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2016
Estimated Enrollment :
30804 Patients enrolled
Trial Details
Trial ID
NCT01155193
Start Date
September 1 2002
End Date
July 31 2016
Last Update
October 29 2018
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