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NCT01053663 · ClinicalTrials.gov registry record · Phase 1
A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01053663 is a Phase 1 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 9 participants.
The verdict
NCT01053663, a Phase 1 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This open-label study will assess the pharmacokinetics and safety of oseltamivir \[Tamiflu\] in 3 cohorts of infants, aged 0-30 days, 31-90 days and 91-\<365 days with influenza infection. Patients will receive 10 doses of intravenous oseltamivir \[Tamiflu\] therapy over 5 or 6 days. Optional oral therapy with oseltamivir \[Tamiflu\] may be considered following the intravenous dose associated with pharmacokinetic blood sampling. Evidence of continued virus shedding at day 6 can allow for up to 5 additional days (10 doses) of oral or intravenous administration. Anticipated time on study drug is 5-11 days. Target sample size is \<50 patients.
Interventions
- DRUG Tamiflu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01053663
The ClinicalTrials.gov registry entry for NCT01053663 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tamiflu is the first listed.
NCT01053663 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01053663 about?
NCT01053663 is a clinical study titled "A Study of Intravenous Oseltamivir [Tamiflu] in Infants With Influenza". This open-label study will assess the pharmacokinetics and safety of oseltamivir \[Tamiflu\] in 3 cohorts of infants, aged 0-30 days, 31-90 days and 91-\<365 days with influenza infection. Patients will receive 10 doses of intravenous oseltamivir \[Tamiflu\] therapy over 5 or 6 days. Optional oral t...
What is the current status of trial NCT01053663?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2011-01. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01053663?
The interventions under investigation include: Tamiflu (DRUG).
Who is sponsoring clinical trial NCT01053663?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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