Phase 3
N=100
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT06774859 ↗Enrolled (actual)
100
Serious AEs
2.0%
Results posted
Apr 2026
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 24; 12; 2; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Baloxavir Marboxil (Drug); Oseltamivir (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
24; 12; 2; 0 | — |
| SECONDARY Time to Alleviation of Influenza Signs and Symptoms (TTAS) |
126.1; 119.5 | — |
| SECONDARY Duration of Fever |
28.3; 36.1 | — |
| SECONDARY Duration of Symptoms |
43.9; 51.9 | — |
| SECONDARY Time to Return to Normal Health and Activity Based on the CARIFS Questionnaire |
126.0; 115.3 | — |
| SECONDARY Number of Participants With Influenza-related Complications |
2; 0 | — |
| SECONDARY Percentage of Participants Requiring Antibiotics for Influenza-related Complications |
1.6; 0 | — |
| SECONDARY Time to Cessation of Viral Shedding by Virus Titer |
23.2; 100.7 | — |
| SECONDARY Time to Cessation of Viral Shedding by Reverse Transcriptase - Polymerase Chain Reaction (RT-PCR) Using Samples From Respiratory Swabs |
218.4; 238.6 | — |
| SECONDARY Change From Baseline in Influenza Virus Titer Over Time Using Samples From Respiratory Swabs |
4.41; 5.21; -3.61; -3.11; -3.65; -3.06 | — |
| SECONDARY Change From Baseline in Amount of Virus RNA (RT-PCR) at Each Timepoint Using Samples From Respiratory Swabs |
7.00; 7.43; -1.76; -1.37; -2.79; -1.82 | — |
| SECONDARY Percentage of Participants With Positive Influenza Virus Titer Over Time |
100.0; 100.0; 11.1; 85.7; 6.0; 65.4 | — |
| SECONDARY Percentage of Participants Positive by RT-PCR at Each Timepoint Using Samples From Respiratory Swabs |
100.0; 100.0; 98.3; 100.0; 91.4; 96.4 | — |
| SECONDARY Area Under the Curve (AUC) in Virus Titer |
-536.09; -610.11 | — |
| SECONDARY AUC in the Amount of Virus RNA (RT-PCR) Using Samples From Respiratory Swabs |
-390.08; -388.13 | — |
| SECONDARY Plasma Concentrations of S-033447 (Active Metabolite) |
75.49; 125.25; 43.15; 15.86 | — |
| SECONDARY Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) of S-033447 |
9550; 11800 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of S-033447 |
182; 159 | — |
| SECONDARY Time of Maximum Observed Concentration (Tmax) of S-033447 |
3.75; 4.25 | — |
| SECONDARY Elimination Half-life (t1/2) of S-033447 |
30.0; 45.8 | — |
| SECONDARY Percentage of Participants With Polymorphic and Treatment-emergent Amino Acid Substitutions in the Polymerase Acidic (PA) Gene |
10.64; 100.00; 0.00 | — |
| SECONDARY Drug Susceptibility in Participants With Evaluable Virus |
4.224; 2.226; 1.904 | — |
| SECONDARY Percentage of Participants With Responses to Palatability and Acceptability Questionnaire |
39.4; 31.8; 6.1; 18.2; 4.5; 65.2 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT06774859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.