A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza

Status:	Completed
Conditions:	Influenza
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	Any
Updated:	2/4/2013
Start Date:	January 2010
End Date:	January 2013
Contact:	Please reference Study ID Number: NV25118 www.roche.com/about_roche/roche_worldwide.htm
Email:	genentechclinicaltrials@druginfo.com
Phone:	888-662-6728 (U.S. Only)

A Multicenter Study of the Safety of Oseltamivir Administered Intravenously for the Treatment of Influenza in Patients Aged Greater Than or Equal to 13 Years

This 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, 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.

Inclusion Criteria:

- Adult and adolescent patients, 13 years of age and older

- Diagnosis of influenza

-
Non-randomized, open-label treatment group:

- Patients with moderate/severe renal impairment or renal failure with creatinine
clearance 10-50 mL/min

Exclusion Criteria:

- Clinical evidence of severe hepatic decompensation at the time of randomization

- Acute ischemia or significant arrhythmia

We found this trial at

sites

Clinical Trial Facility in Newark Delaware

Newark, Delaware 19718

from

Newark, DE