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 study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Cities
  • Bardstown
  • Bydgoszcz
  • Chicago
  • Dallas
  • Dziekanów Leśny
  • Germiston
  • Houston
  • Idaho Falls
  • Jonesboro
  • Kempton Park
  • Madrid
  • Montana
  • Petah Tikva
  • Polokwane
  • Pretoria
  • Ruse
  • San Antonio
  • San José
  • Santiago de Compostela
  • Soshanguve
  • Tampa
  • Tampere
  • therapeutica
  • Łęczna
Trial Identifier:

NCT03653364 2018-002154-70 CP40559

  • Ann & Robert H. Lurie Children's Hospital of Chicago;Division of Infectious Disease

    225 E Chicago Ave60611ChicagoUnited States
  • Clalit Health Services- Pediatric Ambulatory Clinic; Pediatric Ambulatory Clinic

    119 Rothschild StPetah TikvaIsrael
  • Clinical Research Prime

    187 E 13th St83404Idaho FallsUnited States
  • Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría

    s/n Rúa da Choupana15706Santiago de CompostelaSpain
  • GAMA; Clinical Research

    1400GermistonSouth Africa
  • Global Clinical Trials; Clinical Trials

    0001PretoriaSouth Africa
  • Hospital Universitario 12 de Octubre; Servicio de Pediatria

    s/n Av. de Córdoba28041MadridSpain
  • ICIMED Instituto de Investigación en Ciencias Médicas

    San JoséCosta Rica
  • IN VIVO Sp. z o.o.

    17H Kaszubska85-048BydgoszczPoland
  • Kentucky Pediatric Research Center

    40004BardstownUnited States
  • Mercury Clinical Research

    HoustonUnited States
  • Metropolitan Clinical Research Institute

    0699PolokwaneSouth Africa
  • MHAT Stamen Iliev AD

    3400MontanaBulgaria
  • NZOZ Salmed

    3 Wacława Jawoszka21-010ŁęcznaPoland
  • NZOZ Vitamed

    35 Tadeusza Kościuszki85-079therapeuticaPoland
  • Oak Cliff Research Company, LLC

    DallasUnited States
  • Peermed Clinical Trial Centre

    1619Kempton ParkSouth Africa
  • Pholosho Netcare; Netcare Hospital

    0699PolokwaneSouth Africa
  • Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Lesnym

    65 Marii Konopnickiej05-092Dziekanów LeśnyPoland
  • Setshaba Research Centre; Clinical Research

    2088 Block H0152SoshanguveSouth Africa
  • SHAT for Pneumo-Phtysiatric Diseases ?Dr. Dimitar Gramatikov?; Dept. of Pulmonology and Phtisiatrics

    7002RuseBulgaria
  • TAYS Lastenklinikka; Lasten lääketutkimuskeskus Peetu

    2 Kuntokatu33520TampereFinland
  • Tekton Research

    4805 Fredericksburg Rd78229San AntonioUnited States
  • The Children's Clinic of Jonesboro, P.A.

    616 Southwest Dr72401JonesboroUnited States
  • The scientific-research institute of epidemiology; Infectious clinical hospital ?2 of Moscow H.D.

    Russia
  • Usf Health

    2 Tampa General Cir33606TampaUnited States
  • Wojewodzki Szpital Obserwacyjno-Zakazny; Oddzia? Pediatrii, Chorób Infekcyjnych i Hepatologii

    12 Świętego Floriana85-030BydgoszczPoland
    Show study locations

    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

    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 2. 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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