This Study Will Evaluate the Safety, Tolerability, Activity of the Drug in the Body and Effectiveness of Baloxavir Marboxil Given as Granules in a Single Dose to Otherwise Healthy Children with Influenza
- Conditions
- InfluenzaTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-001026-22-Outside-EU/EEA
- Lead Sponsor
- Shionogi & Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
- Male or female patients whose body weight at Screening is less than 20 kg and aged less than 12 years when informed consent obtained from the patient’s parent/legally acceptable representative and/or informed assent obtained, as appropriate to the age of patient. If the patient is younger than 1 year of age, he/she had to have body weight no less than 2500 g at birth.
- Patients with a diagnosis of influenza virus infection confirmed by all of the following: fever =/> 38 C (axillary temperature) at Screening visit and positive rapid influenza diagnostic test (RIDT) by nasopharyngeal (if difficult, nasal or throat) swabs.
- Patients with onset of symptoms within 48 hours at the time of informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Patients with severe symptoms of influenza virus infection requiring inpatient treatment.
- Patients with any of the following high risk factors: chronic respiratory diseases, neurological and neurodevelopmental disorders, heart disease, blood disorders, endocrine disorders, kidney disorders, liver disorders, metabolic disorders, compromised immune system.
- Patients with any disturbance of consciousness, abnormal behavior or convulsions at Screening, or with a current condition of encephalitis or encephalopathy.
- Patients with history of encephalitis, encephalopathy, epilepsy, or influenza virus infection associated abnormal behavior within the past 2 years.
- Patients with concurrent infections requiring systemic antimicrobial and/or antiviral therapy at Screening.
- Patients who have received baloxavir marboxil (Xofluza®), peramivir (Rapiacta®), laninamivir (Inavir®), oseltamivir (Tamiflu®), zanamivir (Relenza®) or amantadine (Symmetrel®) within 30 days prior to Screening (including prophylaxis).
- Patient with known allergy and/or history of significant intolerance against baloxavir marboxil and/or acetaminophen.
- Patients with severe underlying diseases.
- Patients who have been exposed to an investigational drug within 30 days or 5 half-lives of the drug prior to Screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To assess the efficacy of baloxavir marboxil 2% granules in otherwise healthy pediatric subjects weighing less than 20 kg with influenza virus infection.<br>- To assess the safety and tolerability of a single dose of baloxavir marboxil 2% granules in pediatric patients weighing less than 20 kg. <br>-To assess the pharmacokinetics (PK) of S-033447, the active form of S-033188 (baloxavir marboxil), after single dose administration of baloxavir marboxil 2% granules in pediatric patients weighing less than 20 kg.<br>;Secondary Objective: Not applicable;Primary end point(s): Time to alleviation of influenza illness;Timepoint(s) of evaluation of this end point: Day 1 through Day 14
- Secondary Outcome Measures
Name Time Method