Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms
NCT ID: NCT06774859
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2024-10-27
2025-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Baloxavir Marboxil
Participants will receive a single oral dose of baloxavir marboxil on Day 1 based on body weight.
Baloxavir Marboxil
Baloxavir marboxil will be administered as oral suspension: 2 milligrams per kilograms (mg/kg) (if weight \< 20 kg), 40 mg (if weight ≥ 20 kg to \< 80 kg), or 80 mg (if weight ≥ 80 kg).
Oseltamivir
Participants will receive oseltamivir twice a day for 5 days based on body weight.
Oseltamivir
Oseltamivir will be administered as oral capsule: 30 mg (if weight ≤15 kg), 45 mg (if weight \> 15 kg to ≥ 23 kg), 60 mg (if weight \> 23 kg to ≤ 40 kg) or 75 mg (if weight \> 40 kg), twice daily (BID) for 5 days.
Interventions
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Baloxavir Marboxil
Baloxavir marboxil will be administered as oral suspension: 2 milligrams per kilograms (mg/kg) (if weight \< 20 kg), 40 mg (if weight ≥ 20 kg to \< 80 kg), or 80 mg (if weight ≥ 80 kg).
Oseltamivir
Oseltamivir will be administered as oral capsule: 30 mg (if weight ≤15 kg), 45 mg (if weight \> 15 kg to ≥ 23 kg), 60 mg (if weight \> 23 kg to ≤ 40 kg) or 75 mg (if weight \> 40 kg), twice daily (BID) for 5 days.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
11 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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The First People's Hospital of Changde
Changde, , China
Peoples Hospital of Hunan Province
Changsha, , China
Hunan Provincial Maternal and Child Health Care Hospital
Changsha, , China
Chengdu Women's and Children's Central Hospital
Chengdu, , China
Chongqing University Jiangjin Hospital
Chongqing, , China
Childern's Hospital of Chongqing Medical University
Chongqing, , China
Cnpc Central Hospital
Langfang, , China
Liaocheng people's Hospital
Liaocheng, , China
Linfen Central Hospital
Linfen, , China
Liuzhou People's Hospital
Liuzhou, , China
Ningbo Women and Children's Hospital
Ningbo, , China
Sanmenxia Central Hospital
Sanmenxia, , China
The Third People's Hospital of Hainan Province
Sanya, , China
The Second Affiliated Hospital of Shantou University Medical College
Shantou, , China
The First Affiliated Hospital, Shaoyang University
Shaoyang, , China
University of Chinese Academy of Sciences Shenzhen Hospital
Shenzhen, , China
Xiamen Maternal and Child Health Hospital
Xiamen, , China
Yuncheng Central Hospital
Yuncheng, , China
Countries
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Other Identifiers
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YV44465
Identifier Type: -
Identifier Source: org_study_id
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