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NCT04484935 · ClinicalTrials.gov registry record · Phase 2
Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT04484935 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 100 participants.
The verdict
NCT04484935, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
Study D5290C00008 is a Phase 2, open-label, uncontrolled, single-dose study to evaluate the safety and tolerability, pharmacokinetic(s) (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.
Interventions
- DRUG Nirsevimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-08-19 |
| Est. Completion | 2023-02-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04484935
The ClinicalTrials.gov registry entry for NCT04484935 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nirsevimab is the first listed.
NCT04484935 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04484935 about?
NCT04484935 is a clinical study titled "Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children". Study D5290C00008 is a Phase 2, open-label, uncontrolled, single-dose study to evaluate the safety and tolerability, pharmacokinetic(s) (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....
What is the current status of trial NCT04484935?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2020-08-19. Estimated completion is 2023-02-17.
What interventions are being tested in trial NCT04484935?
The interventions under investigation include: Nirsevimab (DRUG).
Who is sponsoring clinical trial NCT04484935?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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