Phase 3
Completed N=49
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms
Source: ClinicalTrials.gov NCT03653364 ↗Enrolled (actual)
49
Serious AEs
4.2%
Results posted
May 2024
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 23; 2 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in healthy pediatric participants from birth to <1 year with influenza like symptoms
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
23; 2 | — |
| SECONDARY Plasma Concentrations of Baloxavir Marboxil and S-033447 |
0.93; 0; 0; 0; 0; 81.98 | — |
| SECONDARY Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of Baloxavir Marboxil and S-033447 |
NA; 5070 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Baloxavir Marboxil and S-033447 |
NA; 127 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of Baloxavir Marboxil and S-033447 |
NA; 4.5 | — |
| SECONDARY Apparent Half-Life (T1/2) of Baloxavir Marboxil and S-033447 |
NA; 23.1 | — |
| SECONDARY Time to Alleviation of Influenza Signs and Symptoms |
163.7 | — |
| SECONDARY Duration of Fever |
23.1 | — |
| SECONDARY Duration of Symptoms |
163.7 | — |
| SECONDARY Time to Return to Normal Health and Activity |
140.7 | — |
| SECONDARY Number of Participants With Influenza-Related Complications |
— | — |
| SECONDARY Number of Participants Requiring Antibiotics |
— | — |
| SECONDARY Time to Cessation of Viral Shedding by Virus Titer |
24.5 | — |
| SECONDARY Time to Cessation of Viral Shedding by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) |
219.1 | — |
| SECONDARY Change From Baseline in Influenza Virus Titer Over Time |
3.58; -2.50; -2.60; -2.43; -2.83; -1.69 | — |
| SECONDARY Change From Baseline in the Amount of Virus RNA (RT-PCR) Over Time |
6.46; -2.26; -1.93; -1.76; -3.30 | — |
| SECONDARY Percentage of Participants With Positive Influenza Virus Titer Over Time |
100; 40; 20; 30; 0; 0 | — |
| SECONDARY Percentage of Participants Positive by RT-PCR Over Time |
100; 92.3; 92.3; 64.3; 42.9; 0 | — |
| SECONDARY Area Under the Concentration-Time Curve (AUC) in Virus Titer |
405.23 | — |
| SECONDARY Area Under the Curve in the Amount of Virus RNA (RT-PCR) |
779.06 | — |
Eligibility Criteria
Inclusion Criteria
- Age from birth to < 1 year at screening
- Written informed consent for study participation obtained from participant's parents or legal guardian
- Parent/guardian willing and able to comply with study requirements, in the investigator's judgment
- Participants with a diagnosis of influenza virus infection confirmed by the presence of all of the following:
- In the investigator's judgement there is a clinical suspicion of influenza
- At least one respiratory symptom (either cough or coryza)
(b) Positive prescreening influenza test (RIDT or PCR) performed within 48 hours of screening
- Participants with a negative prescreening COVID-19 test (RAT or PCR) within 48 hours of screening
- The time interval between the onset of symptoms and screening is ≤ 96 hours (the onset of symptoms is defined as the time when body temperature first exceeded 37.5°C if known, or the time when the first symptom was noticed by the parent or caregiver)
Exclusion Criteria
- Hospitalized for complications of influenza or significant comorbidities
- Concurrent infections requiring systemic antiviral therapy at screening
- Require, in the opinion of the investigator, any of the prohibited medication during the study
- Preterm neonates (born at < 37 weeks gestation) and/or weighing < 2.5 kg at screening
- Previous treatment with peramivir, laninamivir, oseltamivir, zanamivir, or amantadine within 2 weeks prior to screening
- Immunization with a live/attenuated influenza vaccine during the 2 weeks prior to screening
- Concomitant treatment with steroids or other immuno-suppressant therapy
- Known HIV infection or other immunosuppressive disorder
- Uncontrolled renal, vascular, neurologic or metabolic disease (e.g., diabetes, thyroid disorders, adrenal disease), hepatitis, cirrhosis, or pulmonary disease or participants with known chronic renal failure
- Active cancer at any site
- History of organ transplant
- Known hypersensitivity to study drug (i.e., baloxavir marboxil) or to acetaminophen
- Participation in a clinical trial within 4 weeks or five half-lives of exposure to an investigational drug prior to screening, whichever is longer
Data sourced from ClinicalTrials.gov (NCT03653364). 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. Informational only — not medical advice.