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

Completed · Phase 3

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT01050257

Run by

Hoffmann-La Roche

People needed

118

Starts

2010-01-01

Expected to finish

2012-09-01

Last updated by the study team

2013-11-01

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult and adolescent patients, 13 years of age and older
• Diagnosis of influenza
• ≤ 144 hours between the onset of influenza-like illness and first dose of study drug
• Non-randomized, open-label treatment group:
• Patients with moderate/severe renal impairment or renal failure with creatinine clearance 10-60 mL/min

You may not qualify if…

• Clinical evidence of severe hepatic decompensation at the time of randomization
• Acute ischemia or significant arrhythmia

Where it is running

• Study site — Montgomery, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Duarte, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Wilmington, Delaware, United States
• Study site — Melbourne, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Maywood, Illinois, United States
• Study site — Des Moines, Iowa, United States
• Study site — Kansas City, Kansas, United States
• Study site — Overland Park, Kansas, United States
• Study site — Wichita, Kansas, United States
• Study site — Madisonville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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