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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
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Study Identifier
NCT06774859, YV44465
Condition
Influenza
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
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.
Eligibility Criteria
All
≥1 Year & ≤ 11 Years
No
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
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 information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com