Clareo Health | Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
1–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Aged 1 to \< 12 years at randomization (Day 1).
Written informed consent/assent for study participation obtained from participant's parents or legal guardian, with assent as appropriate by the participant, depending on the patient's level of understanding
Participant able to comply with study requirements, depending on the patient's level of understanding
Participant with a diagnosis of influenza virus infection confirmed by the presence of all of the following:
Fever ≥ 38 degree celsius (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
You may not be if
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 participants 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 with child-bearing potential
Participation in a clinical trial within 4 weeks or five half-lives of exposure to an investigational drug prior to screening, whichever is longer
