Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms

  • 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:


This trial runs in
  • Bardstown
  • Bydgoszcz
  • Chicago
  • Ciudad de México
  • Dallas
  • Dziekanów Leśny
  • Germiston
  • Houston
  • Idaho Falls
  • Jonesboro
  • Kempton Park
  • Kuyavian-Pomeranian Voivodeship
  • Madrid
  • Montana
  • Moscow
  • Moskva
  • Petah Tikva
  • Polokwane
  • Pretoria
  • Ruse
  • San Antonio
  • San Diego
  • San José
  • Santiago de Compostela
  • Soshanguve
  • Tampa
  • Tampere
  • therapeutica
Trial Identifier:

NCT03653364 2018-002154-70 CP40559

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      Trial Summary

      This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in healthy pediatric participants from birth to <1 year with influenza like symptoms

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT03653364,CP40559,2018-002154-70 Trial Identifier
      Baloxavir Marboxil Treatments
      Influenza Condition
      Official Title

      A Multicenter, Single-Arm, Open-Label Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients From Birth to < 1 Year With Influenza-Like Symptoms

      Eligibility Criteria

      All Gender
      ≤ 1 Year Age
      No Healthy Volunteers
      Inclusion Criteria
      • Age from birth to < 1 year at screening
      • Written informed consent for study participation obtained from participant's parents or legal guardian
      • Parent/guardian willing and able to comply with study requirements, in the investigator's judgment
      • Participants with a diagnosis of influenza virus infection confirmed by the presence of all of the following:
      • In the investigator's judgement there is a clinical suspicion of influenza
      • At least one respiratory symptom (either cough or coryza)

      (b) Positive prescreening influenza test (RIDT or PCR) performed within 48 hours of screening

      • Participants with a negative prescreening COVID-19 test (RAT or PCR) within 48 hours of screening
      • The time interval between the onset of symptoms and screening is ≤ 96 hours (the onset of symptoms is defined as the time when body temperature first exceeded 37.5°C if known, or the time when the first symptom was noticed by the parent or caregiver)
      Exclusion Criteria
      • Hospitalized for complications of influenza or significant comorbidities
      • Concurrent infections requiring systemic antiviral therapy at screening
      • Require, in the opinion of the investigator, any of the prohibited medication during the study
      • Preterm neonates (born at < 37 weeks gestation) and/or weighing < 2.5 kg at screening
      • Previous treatment with peramivir, laninamivir, oseltamivir, zanamivir, or amantadine within 2 weeks prior to screening
      • Immunization with a live/attenuated influenza vaccine during the 2 weeks prior to screening
      • Concomitant treatment with steroids or other immuno-suppressant therapy
      • Known HIV infection or other immunosuppressive disorder
      • Uncontrolled renal, vascular, neurologic or metabolic disease (e.g., diabetes, thyroid disorders, adrenal disease), hepatitis, cirrhosis, or pulmonary disease or participants with known chronic renal failure
      • Active cancer at any site
      • History of organ transplant
      • Known hypersensitivity to study drug (i.e., baloxavir marboxil) or to acetaminophen
      • Participation in a clinical trial within 4 weeks or five half-lives of exposure to an investigational drug prior to screening, whichever is longer

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