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A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza - NCT01050257-10007(Clinical Trial 465226)



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City:  New York
State:  
NY
Zip Code: 10007
Conditions: Influenza
Purpose: 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.
Study summary:
Criteria: Inclusion Criteria: - Adult and adolescent patients, 13 years of age and older - Diagnosis of influenza - </=96 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 10-50 mL/min Exclusion Criteria: - Clinical evidence of severe hepatic decompensation at the time of randomization - Acute ischemia or significant arrhythmia
Study is available at:
New York, NY 10007
United States

Primary Contact:
Please reference Study ID Number: NV25118
Email: genentechclinicaltrials@druginfo.com
Phone: 888-662-6728 (U.S. Only)
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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