A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Oseltamivir

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

- 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