An Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Baloxavir Marboxil 2% Granules after Administration of a Single Dose to Otherwise Healthy Pediatric Patients with Influenza

Shionogi & Co., Ltd.0 个研究点开始时间: 2021年3月5日最近更新: 2021年3月8日

适应症

试验速览

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•- 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.

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