A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE (OSELTAMIVIR)-CONTROLLED STUDY TO ASSESS THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF BALOXAVIR MARBOXIL IN OTHERWISE HEALTHY PEDIATRIC PATIENTS 1 TO <12 YEARS OF AGE WITH INFLUENZA-LIKE SYMPTOMS

F. Hoffmann-La Roche Ltd0 个研究点目标入组 173 人开始时间: 2018年12月10日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•- Aged 1 to < 12 years at randomization (Day 1)
•- Parent/guardian willing and able to comply with study requirements, in the investigator’s judgment
•- Patient able to comply with study requirements, depending on the patient’s level of understanding
•- Patient with a diagnosis of influenza virus infection confirmed by the presence of all of the following:
•? Fever >=38 degrees C (tympanic temperature) at screening
•? At least one respiratory symptom (either cough or nasal congestion)
•- The time interval between the onset of symptoms and screening is <= 48 hours (the onset of symptoms is defined as the time when body temperature first exceeded 37.5 degrees C if known, or the time when the first symptom was noticed by patient, parent or caregiver)
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•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

•- Severe symptoms of influenza virus infection requiring inpatient treatment
•- Concurrent infections requiring systemic antiviral therapy at screening
•- Require, in the opinion of the investigator, any of the prohibited medication during the study
•- Previous treatment with peramivir, laninamivir, oseltamivir, zanamivir, or amantadine within 2 weeks prior to screening
•- Immunization with a live/attenuated influenza vaccine in the 2 weeks prior to randomization
•- 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 patients with known chronic renal failure
•- Active cancer at any site
•- History of organ transplantation
•- Known allergy to either study drug (i.e., baloxavir marboxil and oseltamivir) or to acetaminophen
•- Females who have commenced menarche (i.e., child-bearing potential)
•- Participation in a clinical trial within 4 weeks or 5 half-lives of exposure to an investigational drug prior to screening, whichever is longer

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