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A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain - NCT01032837-13790(Clinical Trial 478354)



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City:  Johnson City
State:  
NY
Zip Code: 13790
Conditions: Influenza
Purpose: This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza strain or influenza A are eligible for this study. Patients will be randomized to one of four treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg (adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body weight-adjusted for pediatric patients. The target sample size is 300-500 patients.
Study summary:
Criteria: Inclusion Criteria: - Pediatric, adolescent and adult patients >/=1 year of age - Fever >/=37.8 degrees C or at least one respiratory symptom (cough, coryza, sore throat, or rhinitis) - Positive rapid diagnostic test for pandemic (H1N1) 2009 virus or influenza A in the 24 hours prior to the first dose of study drug - </=96 hours between onset of influenza-like illness and first dose of oseltamivir Exclusion Criteria: - Currently receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis, or hemofiltration - History of chronic renal failure or clinical suspicion of renal failure at baseline - Clinical evidence of hepatic compensation at the time of randomization - Known HIV infection - Vaccination with live attenuated influenza vaccine (LAIV) in the two weeks prior to first dose of study medication
Study is available at:
Johnson City, NY 13790
United States

Primary Contact:
Please reference Study ID Number: NV22155
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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