Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04484935
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2020-06-30
Brief Title:
Evaluate the Safety and Tolerability for Nirsevimab in Immunocompromised Children
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase 2 Open-label Uncontrolled Single-dose Study to Evaluate the Safety and Tolerability Pharmacokinetics and Occurrence of Antidrug Antibody for Nirsevimab in Immunocompromised Children 24 Months of Age
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MUSIC
Brief Summary:
Study D5290C00008 is a Phase 2 open-label uncontrolled single-dose study to evaluate the safety and tolerability pharmacokinetics PK occurrence of antidrug antibody ADA and efficacy of nirsevimab in immunocompromised children who are 24 months of age at the time of dose administration Approximately 100 subjects will be enrolled Subjects will be followed for approximately 1 year after dose administration
Detailed Description:
Respiratory syncytial virus RSV is the most common cause of lower respiratory tract infection LRTI among infants and young children resulting in annual epidemics in Japan Children with congenital or acquired immunodeficiencies transplant recipients and those receiving immunosuppressive therapy are at increased risk for severe RSV-associated LRTI with prolonged viral shedding and higher viral loads resulting in prolonged hospitalizations admissions to the intensive care unit ICU and the need for mechanical ventilation Palivizumab Synagis is the only approved agent for RSV prophylaxis and its half-life t12 is approximately 1 month infants and young children need to receive monthly intramuscular doses of palivizumab throughout the RSV season to maintain protection This constitutes a significant burden on healthcare providers as well as the infantschildren and their families
Nirsevimab may provide a cost-effective opportunity to protect all infants from RSV disease based on an improvement in potency and the extended t12 that is expected to support once-per-RSV-season dosing
Nirsevimab may provide a cost-effective opportunity to protect all infants from RSV disease based on an improvement in potency and the extended t12 that is expected to support once-per-RSV-season dosing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-003221-30 | EUDRACT_NUMBER | None | None |