An open label, single arm study to evaluate single and multiple dose pharmacokinetics, safety and tolerability, and to explore clinical outcomes of treatment with intravenous |(IV) zanamivir in neonates and infants under 6 months of age with confirmed complicated influenza infection - 200925 - Influenza

GlaxoSmithKline0 个研究点目标入组 3 人开始时间: 待定最近更新: 2024年4月9日

研究概览

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•1. Neonates and infants who are aged less than 6 months (corrected age).
•Preterm neonates and infants will be eligible for inclusion but must have
•reached Post-Menstrual Age (PMA) of at least 28 weeks
•2. Participants who are hospitalised with influenza infection.
•3.Participants with a high risk of altered oral drug absorption, represented by
•multi-organ dysfunction (dysfunction of at least 2 organs, as defined by the
•treating physician).
•4. Body weight >=1kg

•1. Participants who are known or suspected to be hypersensitive to any
•component of the study medication.
•2. Participants with a disease process which is likely to be irreversible.
•3. Liver function:
•Subjects who meet the following criteria at Baseline:
•ALT >=3xULN with Bilirubin >=2xULN, or Isolated bilirubin >= 2xULN and >50% direct
•bilirubin, or ALT >=5xULN
•Current or chronic history of liver disease or known hepatic or biliary
•abnormalities.
•4. Participants who require concurrent therapy with another influenza antiviral
•5. Participants who have participated in a study using an investigational drug
•within 30 days prior to Baseline.
•6. Child in care (CiC), as defined below:
•A child who has been placed under the control or protection of an agency,
•organisation, institution or entity by the courts, the government or a
•government body, acting in accordance with powers conferred on them by law or
•regulation.
•The definition of a CiC can include a child cared for by foster parents or
•living in a care home or institution, provided that the arrangement falls
•within the definition above. The definition of a CiC does not include a child
•who is adopted or has an appointed legal guardian.
•7. Patients undergoing treatment by Extracorporeal membrane oxygenation (ECMO)
•or hemofiltration.
•8. Participants who are positive for SARS-CoV-2, as determined by a diagnostic
•test, at screening

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