Influenza > Oseltamivir
~1 spots leftby Apr 2026

A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza

Recruiting in Palo Alto (17 mi)
+34 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Hoffmann-La Roche
No Placebo Group
Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2 years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10 doses). For patients whose conditions no longer merit continued iv dosing, therapy may be switched to oral Tamiflu to complete their prescribed course of treatment. If medically necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days. Anticipated time on study treatment is 5 to 10 days.

Eligibility Criteria

Inclusion Criteria

children, 1-12 years of age
diagnosis of influenza
duration of influenza symptoms </=96 hours prior to first dose of study drug

Treatment Details

Interventions

  • Oseltamivir (Neuraminidase Inhibitor)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention

Oseltamivir is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Tamiflu for:
  • Influenza A and B virus infections
🇺🇸 Approved in United States as Tamiflu for:
  • Acute uncomplicated influenza A and B virus infections
  • Prophylaxis of influenza A and B virus infections
🇨🇦 Approved in Canada as Tamiflu for:
  • Acute uncomplicated influenza A and B virus infections
  • Prophylaxis of influenza A and B virus infections
🇯🇵 Approved in Japan as Tamiflu for:
  • Influenza A and B virus infections

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
NCT01033734Dayton, OH
NCT01033734Duluth, MN
NCT01033734Los Angeles, CA
NCT01033734Raleigh, NC
More Trial Locations
Loading ...

Who Is Running the Clinical Trial?

Hoffmann-La RocheLead Sponsor

References

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top