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

Phase 1

• Conditions: Influenza; MedDRA version: 19.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-001008-49-Outside-EU/EEA
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-30
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 400

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
- Are the trial subjects under 18? yes
Number of subjects for this age range: 200
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified