Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 1 study, sponsored by Hoffmann-La Roche.
NCT01053663 is a Phase 1 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT01053663 stopped before completion
NCT01053663 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Tamiflu is the first listed.
NCT01053663 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01053663's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia