Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pedia… (NCT06774859) | Clinical Trial Compass
CompletedPhase 3
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms
China100 participantsStarted 2024-10-27
Plain-language 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.
Who can participate
Age range1 Year – 11 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 scre…
What they're measuring
1
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)