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 sites3 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•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

Not specified