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

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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]

Trial contacts and locations

38

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Data sourced from clinicaltrials.gov

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