Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms

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

Recruiting

This study runs in
Country
  • China
Study Identifier:

NCT06774859 YV44465

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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 study 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

      Study Summary

      The purpose of this study is to evaluate the safety of a single dose baloxavir marboxil compared with 5 days of oseltamivir administered twice a day (BID) in Chinese pediatric participants aged 1 to < 12 years with influenza symptoms.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT06774859, YV44465 Study Identifier
      Baloxavir Marboxil, Oseltamivir Treatments
      Influenza Condition
      Official Title

      A Phase III, Randomized, Open-Label, Active-Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Patients 1 to <12 Years of Age With Influenza Symptoms

      Eligibility Criteria

      All Gender
      ≥1 Year & ≤ 11 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • A participant who has a diagnosis of influenza virus infection and meets all the following conditions:
      • Fever ≥ 38°C (tympanic temperature) at screening
      • At least one of the respiratory symptoms of influenza virus infection
      • A rapid influenza diagnostic test (RIDT) or polymerase chain reaction (PCR) shows positive for influenza A/B, e.g., point-of-care/local laboratory results with use of nasal aspirate, throat swab, or nasal drip/droplet (or other appropriate sample)
      • The time interval between the onset of symptoms and screening is ≤ 48 hours
      • PCR (-) or antigen test (-) for severe acute respiratory virus-coronavirus 2 (SARS-CoV-2) using point-of-care/local laboratory test with nasal aspirate, throat swab, or nasal drip/droplet (or other appropriate sample)
      Exclusion Criteria
      • A participant having severe influenza virus infection symptoms requiring inpatient treatment
      • Received systemic corticosteroid or immunosuppressive therapy
      • Primary immunodeficiency syndrome
      • History of organ transplantation
      • Human immunodeficiency virus (HIV) infection
      • Immunization with a live/attenuated influenza vaccine in 2 weeks prior to randomization
      • Previous malignancy within the last 5 years or has an active cancer at any site
      • A participant who received any medications with anti-flu effect such as baloxavir, peramivir, oseltamivir, zanamivir, favipiravir, arbidol, amantadine or traditional Chinese anti-influenza medicines within 30 days before screening
      • Diagnosed with or suspected SARS-CoV-2 infection, or close contacts of diagnosed or suspected SARS-CoV-2 infected patients
      • Severe underlying disease or condition potentially affecting study evaluation in the opinion of the investigator/sub-investigator
      • A participant who received an investigational or unapproved drug product within 30 days or 5 x the half-life before screening, whichever is longer

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

       

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