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NCT00435227 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness
A Phase 2 study, sponsored by MedImmune.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT00435227: Clinical Trial Phase 2 study, sponsored by MedImmune.
NCT00435227 is a Phase 2 study that was terminated before completion, run by MedImmune. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00435227, a Phase 2 study, was terminated before completion, sponsored by MedImmune.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg 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 1:1 randomization, 30 mg/kg motavizumab or placebo will be administered as soon as possible after a child's diagnosis of RSV and his/her eligibility for the study has been confirmed.
Primary Outcome
The RSV viral load is measured by real-time RT-PCR in the RSV-infected participants. RSV-infected children are those who are positive for any RSV by RT-PCR of nasal wash aspirates.
Interventions
- OTHER Placebo
- BIOLOGICAL Motavizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2007-03-20 |
| Est. Completion | 2008-05-31 |
| Phase | Phase 2 |
Why NCT00435227 stopped before completion
NCT00435227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00435227 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00435227 about?
NCT00435227 is a clinical study titled "A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness". This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg 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 ...
What is the current status of trial NCT00435227?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2007-03-20. Estimated completion is 2008-05-31.
What interventions are being tested in trial NCT00435227?
The interventions under investigation include: Placebo (OTHER), Motavizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00435227?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00435227's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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