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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 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 118 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01050257
The ClinicalTrials.gov registry entry for NCT01050257 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 118 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 2 interventions - of which Oseltamivir IV is the first listed.
NCT01050257 reports 0 study locations.
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.
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