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

Completed · Phase 1

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT01033734

Run by

Hoffmann-La Roche

People needed

8

Starts

2010-12-01

Expected to finish

2012-12-01

Last updated by the study team

2016-08-24

Who can join

Age: 1 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• evidence of severe hepatic decompensation
• patients taking probenecid within 1 week prior to first dose of study drug

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Oakland, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Wilmington, Delaware, United States
• Study site — Jacksonville, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — South Bend, Indiana, United States
• Study site — Wichita, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Duluth, Minnesota, United States
• Study site — Omaha, Nebraska, United States
• Study site — Morristown, New Jersey, United States
• Study site — Brooklyn, New York, United States
• Study site — New York, New York, United States
• Study site — Stony Brook, New York, United States
• Study site — Syracuse, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Akron, Ohio, United States

Full record on ClinicalTrials.gov

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