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

  • Infectious Diseases
  • Influenza
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Countries
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Finland
  • Germany
  • Greece
  • Israel
  • Italy
  • Mexico
  • Poland
  • South Africa
  • Spain
  • United States
Trial Identifier:

NCT01715909 2012-002633-11 NV25719

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT01715909, NV25719, 2012-002633-11 Trial Identifier
      Oseltamivir Treatments
      Influenza Condition
      Official Title

      An Open-Label, Randomized, Adaptive, Two-Arm, Multicenter Trial to Evaluate Pharmacokinetics And Pharmacodynamics of Two Doses of Oseltamivir (Tamiflu®) in The Treatment Of Influenza in Immunocompromised Children Less Than 13 Years Of Age, With Confirmed Influenza Infection

      Eligibility Criteria

      All Gender
      ≤ 12 Years Age
      No Healthy Volunteers
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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