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)

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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
28
sites
1939
mi
from 98109
Louisville, KY
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1903
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from 98109
Ann Arbor, MI
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2187
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Ashville, NC
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1609
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from 98109
Bettendorf, IA
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2079
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from 98109
Birmingham, AL
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2485
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from 98109
Boston, MA
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2020
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from 98109
Cleveland, OH
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1682
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from 98109
Dallas, TX
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2529
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from 98109
Daytona Beach, FL
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2181
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from 98109
Decatur, GA
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1660
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from 98109
Fort Smith, AR
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490
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from 98109
Helena, MT
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Huntington, West Virginia 25701
2087
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from 98109
Huntington, WV
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1983
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from 98109
Jackson, MS
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2091
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from 98109
Metairie, LA
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2400
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from 98109
New York, NY
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from 98109
Newark, DE
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2393
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from 98109
Newark, NJ
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2429
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from 98109
Norfolk, VA
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1366
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from 98109
Omaha, NE
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1503
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from 98109
Overland Park, KS
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1719
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from 98109
Park Ridge, IL
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2373
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from 98109
Philadelphia, PA
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1116
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from 98109
Phoenix, AZ
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1450
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from 98109
Rochester, MN
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710
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from 98109
Santa Clara, CA
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1466
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from 98109
St. Joseph, MO
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1565
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from 98109
Tulsa, OK
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