A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza

Roche

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Drug: oseltamivir [Tamiflu]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01033734

NP25139

Details and patient eligibility

About

This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2 years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10 doses). For patients whose conditions no longer merit continued iv dosing, therapy may be switched to oral Tamiflu to complete their prescribed course of treatment. If medically necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days. Anticipated time on study treatment is 5 to 10 days.

Enrollment: 8 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children, 1-12 years of age
• diagnosis of influenza
• duration of influenza symptoms </=96 hours prior to first dose of study drug

Exclusion criteria

• evidence of severe hepatic decompensation
• patients taking probenecid within 1 week prior to first dose of study drug

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

Single arm

Experimental group

Treatment:

Drug: oseltamivir [Tamiflu]