EUCTR2019-001588-63-NL进行中（未招募）1 期
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 - Zanamivir, Ph 2a, Infant/Neonate complicated Influenza Patients,5-10 Day IV RD, PK/Safety Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Neonates and infants who are aged less than 6 months (corrected age) at the time of the informed consent signed by legally acceptable representative (LAR) of minors. 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, confirmed by a positive rapid molecular diagnostic test for influenza, or a local quantitative RT-PCR test and who must have a potential for improvement Subjects with negative rapid molecular test result suspected of having influenza can be enrolled following confirmatory testing by quantitative RT-PCR.
- •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
- •5.Male or female.
- •6.Legally acceptable representative (LAR) of minors are willing and able to give written informed consent to participate in the study (or included as permitted by local regulatory authorities, IECs or local laws).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
- •Inclusion of subjects with liver function tests that fall outside these criteria must be discussed and agreed with the medical monitor.
- •-Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of benign conditions such as Gilbert's syndrome). Inclusion of subjects with neonatal hyperbilirubinaemia may be considered if appropriately managed according to local guidelines and must be discussed with the medical monitor.
- •4.Participants who require concurrent therapy with another influenza antiviral drug. Antiviral treatment including oseltamivir are prohibited to be co-administered with IV zanamivir. (Section 6.4 in the protocol).
- •5.Prior/Concurrent Clinical Study Experience
- •Participants who have participated in a study using an investigational drug within 30 days prior to Baseline.
- •Other Exclusions
- •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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