A study to look at the safety and effectiveness of baloxavir marboxil in treating children with influenza aged between 1 and <12 years (miniSTONE-2)

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

  • Influenza
Trial Status:

Completed

This trial runs in
Countries
  • Costa Rica
  • Israel
  • Mexico
  • Poland
  • Russia
  • Spain
  • United States
Trial Identifier:

NCT03629184 2018-002169-21 CP40563

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This study will evaluate the safety, pharmacokinetics, and efficacy of baloxavir marboxil compared with oseltamivir in a single influenza episode in otherwise healthy pediatric participants (i.e., 1 to <12 years of age) with influenza-like symptoms.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT03629184 , CP40563 , 2018-002169-21 Trial Identifier
      Baloxavir Marboxil, Oseltamivir Treatments
      Influenza Condition
      Official Title

      A Multicenter, Randomized, Double-Blind, Active (Oseltamivir)-Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients 1 to <12 Years of Age With Influenza-Like Symptoms

      Eligibility Criteria

      All Gender
      ≥1 Year & ≤ 11 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Aged 1 to < 12 years at randomization (Day 1).
      • Written informed consent/assent for study participation obtained from participant's parents or legal guardian, with assent as appropriate by the participant, depending on the patient's level of understanding
      • Participant able to comply with study requirements, depending on the patient's level of understanding
      • Participant with a diagnosis of influenza virus infection confirmed by the presence of all of the following:
      • Fever ≥ 38 degree celsius (tympanic temperature) at screening
      • At least one respiratory symptom (either cough or nasal congestion)
      • The time interval between the onset of symptoms and screening is ≤ 48 hours
      Exclusion Criteria
      • Severe symptoms of influenza virus infection requiring inpatient treatment
      • Concurrent infections requiring systemic antiviral therapy at screening
      • Require, in the opinion of the investigator, any of the prohibited medication during the study
      • Previous treatment with peramivir, laninamivir, oseltamivir, zanamivir, or amantadine within 2 weeks prior to screening
      • Immunization with a live/attenuated influenza vaccine in the 2 weeks prior to randomization
      • 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 transplantation
      • Known allergy to either study drug (i.e., baloxavir marboxil and oseltamivir) or to acetaminophen
      • Females with child-bearing potential
      • Participation in a clinical trial within 4 weeks or five half-lives of exposure to an investigational drug prior to screening, whichever is longer

      Clinical Research Explained

      Information about what clinical trials and observational studies are. Understand why you might want to take part in clinical research and why diversity in clinical research is important.

      Find out now