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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

NCT06774859

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Influenza

Interventions: Baloxavir Marboxil, Oseltamivir

Countries: China

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 overview

Sex: ALL

Age: 1 Year to 11 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (16)

Changde, China
Changsha, China
Chengdu, China
Chongqing, China
Chongqing, China
Langfang, China
Liaocheng, China
Linfen, China
Liuzhou, China
Ningbo, China
Sanmenxia, China
Sanya, China
Shantou, China
Shaoyang, China
Shenzhen, China
Xiamen, China