Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01050257 · ClinicalTrials.gov registry record · Phase 3
A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 118
- Enrollment target
NCT01050257: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01050257 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 118 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01050257, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 118 participants
- Enrollment target
Study Summary
This partially randomized, multi-center parallel-group study will evaluate the safety, pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in patients with influenza. Adult and adolescent patients will be randomized to receive either 100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days, with an optional treatment extension of a further 5 days, if necessary. There will be a non-randomized, open-label treatment group for patients with moderate/severe renal impairment or renal failure. Intravenous dose levels and frequency will be adjusted appropriately to their renal situation.
Primary Outcome
Safety was assessed by adverse events (AEs) as measured by the collection of AEs, vital signs, electrocardiograms and laboratory parameters. An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, si
Interventions
- DRUG Oseltamivir IV
- DRUG Oseltamivir Oral
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
What the finished NCT01050257 record still lists
NCT01050257 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Oseltamivir IV is the first listed.
NCT01050257 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01050257 about?
NCT01050257 is a clinical study titled "A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza". This partially randomized, multi-center parallel-group study will evaluate the safety, pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in patients with influenza. Adult and adolescent patients will be randomized to receive either 100 mg or 200 mg of study dr...
What is the current status of trial NCT01050257?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 2010-01. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01050257?
The interventions under investigation include: Oseltamivir IV (DRUG), Oseltamivir Oral (DRUG).
Who is sponsoring clinical trial NCT01050257?
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 NCT01050257's enrollment target sits among peer trials
118 1641st of 2000 higher than 359 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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 enrollment target
- NCT03821623 · 118 participants · Phase 2
Nicotinamide Riboside for Treating Elevated Systolic Blood Pressure and Arterial Stiffness in Middle-aged and Older Adults
- NCT04040959 · 118 participants · Phase 2
Nicotinamide Riboside Supplementation for Treating Arterial Stiffness and Elevated Systolic Blood Pressure in Patients With Moderate to Severe CKD
- NCT04696029 · 118 participants · Phase 2
DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma
- NCT05223192 · 118 participants · NA
The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants
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