Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435227
Status:
TERMINATED
Last Update Posted:
2021-08-17
First Post:
2007-02-13
Brief Title:
A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus RSV Illness
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Phase 2 Randomized Double-blind Placebo-controlled Study to Evaluate a Single Intramuscular Dose of Motavizumab MEDI-524 a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus RSV for the Outpatient Treatment of Children With RSV Illness
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated early due to an inability to enroll the planned number of participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a Phase 2 randomized double-blind placebo-controlled multicenter study to determine the effect of a single 30 mgkg intramuscular IM dose of motavizumab on viral load and motavizumab levels in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization Using 11 randomization 30 mgkg motavizumab or placebo will be administered as soon as possible after a childs diagnosis of RSV and hisher eligibility for the study has been confirmed
Detailed Description:
This was a Phase 2 randomized double-blind placebo-controlled multicenter study to determine the effect of a single 30 mgkg IM dose of motavizumab on viral load in the upper respiratory tract of children who present with RSV illness but who do not require hospitalization Participants were randomly assigned in a 11 ratio to 30 mgkg motavizumab or placebo as soon as possible after a childs diagnosis of RSV and hisher eligibility for the study had been confirmed Randomization was stratified by age 6 months and greater than or equal to 6 to less than or equal to 12 months of age and by site Enrollment of an initial 100 children 50 per treatment group will take place at multiple sites beginning in the 2006-2007 RSV season The study was terminated early due to inability to enroll the planned number of participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None