drugset / Trial / NCT01715909
A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection
RandomizedParallel-groupOpen-labelTreatment
Summary
This open-label, randomized, adaptive, 2-arm, multicenter study will evaluate the pharmacokinetics and pharmacodynamics of oseltamivir (Tamiflu) in immunocompromised children, less than (\<) 13 years of age, with confirmed influenza infection. Participants will be randomized to receive either the standard dose or triple dose of oseltamivir orally daily for a minimum of 5 days and up to 20 days. Infants \<1 year of age will be randomized to the standard dose arm only.
Timeline
- Start
- 2014-01-22
- Primary completion
- 2018-06-17
- Completion
- 2018-06-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oseltamivir | Small molecule | 3 mg/kg | Oral |
| Subject | Oseltamivir | Small molecule | 30 mg | Oral |
| Subject | Oseltamivir | Small molecule | 45 mg | Oral |
| Subject | Oseltamivir | Small molecule | 60 mg | Oral |
| Subject | Oseltamivir | Small molecule | 75 mg | Oral |
| Subject | Oseltamivir | Small molecule | 90 mg | Oral |
| Subject | Oseltamivir | Small molecule | 225 mg | Oral |