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A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection
A Pharmacokinetic/Pharmacodynamic Study of Oseltamivir in Immunocompromised Children With Confirmed Influenza Infection

NCT01715909

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Influenza

Interventions: Oseltamivir

Countries: United States, Belgium, Brazil, Canada, Chile, Colombia, Finland, Germany

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.

Eligibility overview

Sex: ALL

Age: — to 12 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Male or female children, \<13 years of age
* Rapid influenza diagnostic test (RIDT), polymerase chain reaction (PCR), or viral culture positive for influenza
* Immunocompromised
* Symptoms/signs suggestive of influenza like illness (ILI)
* Less than or equal to (\</=) 96 hours between onset of ILI and first dose of study drug

Exclusion Criteria:

* Clinical evidence of severe hepatic impairment
* Infants with post-menstrual age (PMA) \<36 weeks
* Clinical evidence of significant renal impairment
* Allergy to oseltamivir or excipients
* Hereditary fructose intolerance
* Received anti-viral treatment with activity against influenza (for example amantadine, rimantadine, oseltamivir, laninamivir, peramivir, zanamivir, and ribavirin) or probenecid medication within 2 weeks prior to randomization
Locations (50)
  • Palo Alto, California, United States
  • Aurora, Colorado, United States
  • Boston, Massachusetts, United States
  • Minneapolis, Minnesota, United States
  • Syracuse, New York, United States
  • Cincinnati, Ohio, United States
  • Seattle, Washington, United States
  • Brussels, Belgium
  • Brussels, Belgium
  • Leuven, Belgium
  • Curitiba, Paraná, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • São Paulo, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • Ottawa, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Viña del Mar, Chile
  • Cali, Colombia
  • Cali, Colombia
  • Turku, Finland
  • Berlin, Germany
  • Frankfurt, Germany
  • München, Germany
  • Münster, Germany
  • Tübingen, Germany
  • Athens, Greece
  • Athens, Greece
  • Haifa, Israel
  • Jerusalem, Israel
  • + 20 more on CT.gov