An Open Label, Prospective, Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Oseltamivir (Tamiflu) in the Treatment of Infants 0 to less than 12 Months of Age With Confirmed Influenza Infection.
Phase of Trial: Phase I
Latest Information Update: 23 Mar 2017
At a glance
- Drugs Oseltamivir (Primary)
- Indications Influenza virus infections
- Focus Pharmacokinetics; Registrational
- Sponsors Roche
- 21 Dec 2012 The US FDA extended the approval of oseltamivir to include infants 2 weeks of age and older, based on this and another study, according to a Genentech media release.
- 01 Jul 2012 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
- 17 Mar 2012 Planned number of patients changed from 84 to 85 as reported by European Clinical Trials Database.