A MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO ASSESS THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF BALOXAVIR MARBOXIL IN OTHERWISE HEALTHY PEDIATRIC PATIENTS FROM BIRTH TO LESS THAN 1 YEAR WITH INFLUENZA-LIKE SYMPTOMS - Ministone 1

Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann0 个研究点目标入组 30 人开始时间: 2019年7月4日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•- Age from birth to < 1 year at screening
•- Parent/guardian willing and able to comply with study requirements, in the investigator’s judgment
•- Patients with a diagnosis of influenza virus infection confirmed by the presence of all of the following:
•o Fever >= 38°C (tympanic temperature) at screening
•o At least one respiratory symptom (either cough or coryza)
•- The time interval between the onset of symptoms and screening is <= 96 hours
•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

•- 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)
•- Weigh < 2.5 kg at screening
•o Only children > 4.5 kg will be eligible to take part in countries that have volume limits for blood draws set at 1% of the total blood volume (maximum over 24 hour period) and 3% of the total blood volume (maximum over 30-day period)
•- 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, hepatitis, cirrhosis, or pulmonary disease or patients with known chronic renal failure
•- Active cancer at any site
•- History of organ transplant
•- Known allergy to study drug 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

发起方

Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann