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 | Completed Phase 3 Results

• 1 other identifier: YV44465
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability or incapacity, was a congenital anomaly or birth defect.

  Up to Day 29

Secondary Outcomes (22)

• Time to Alleviation of Influenza Signs and Symptoms (TTAS)

  Up to Day 15

• Duration of Fever

  Up to Day 15

• Duration of Symptoms

  Up to Day 15

• Time to Return to Normal Health and Activity Based on the CARIFS Questionnaire

  Up to Day 15

• Number of Participants With Influenza-related Complications

  Up to Day 29

Study Arms (2)

Baloxavir Marboxil

EXPERIMENTAL

Participants will receive a single oral dose of baloxavir marboxil on Day 1 based on body weight.

Drug: Baloxavir Marboxil

Oseltamivir

ACTIVE COMPARATOR

Participants will receive oseltamivir twice a day for 5 days based on body weight.

Drug: Oseltamivir

Interventions

Baloxavir Marboxil DRUG

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).

Baloxavir Marboxil

Oseltamivir DRUG

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.

Oseltamivir

Eligibility Criteria

• Age: 1 Year - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (16)

The First People's Hospital of Changde

Changde, DUMMY_VALUE, China

Location

Peoples Hospital of Hunan Province

Changsha, 410007, China

Location

Chengdu Women's and Children's Central Hospital

Chengdu, 610091, China

Location

Chongqing University Jiangjin Hospital

Chongqing, 402260, China

Location

Childern's Hospital of Chongqing Medical University

Chongqing, DUMMY_VALUE, China

Location

Hebei Petro China Central Hospital

Langfang, 065000, China

Location

Liaocheng people's Hospital

Liaocheng, 252000, China

Location

Linfen Central Hospital

Linfen, 041000, China

Location

Liuzhou People's Hospital

Liuchow, 545006, China

Location

Ningbo Women and Children's Hospital

Ningbo, 315021, China

Location

Sanmenxia Central Hospital

Sanmenxia, DUMMY_VALUE, China

Location

The Third People's Hospital of Hainan Province

Sanya, 572000, China

Location

The Second Affiliated Hospital of Shantou University Medical College

Shantou, 515051, China

Location

The First Affiliated Hospital, Shaoyang University

Shaoyang, DUMMY_VALUE, China

Location

University of Chinese Academy of Sciences Shenzhen Hospital

Shenzhen, 518107, China

Location

Xiamen Maternal and Child Health Hospital

Xiamen, 361001, China

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

baloxavir; Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: October 27, 2024
• Primary Completion: May 8, 2025
• Study Completion: May 8, 2025
• Last Updated: April 27, 2026
• Results First Posted: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (16)