Clareo Health | Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms
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Keep this study
Lead
Hoffmann-La Roche
Age
0–1
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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:
1. In the investigator's judgement there is a clinical suspicion of influenza
2. 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)
You may not be if
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
