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Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms

NCT03653364

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Influenza

Interventions: Baloxavir Marboxil

Countries: United States, Bulgaria, Costa Rica, Finland, Israel, Poland, Russia, South Africa

This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in healthy pediatric participants from birth to \<1 year with influenza like symptoms

Eligibility overview

Sex: ALL

Age: — to 1 Year

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Locations (27)

Jonesboro, Arkansas, United States
Tampa, Florida, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Bardstown, Kentucky, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Montana, Bulgaria
Rousse, Bulgaria
San José, Costa Rica
Tampere, Finland
Petah Tikva, Israel
??czna, Poland
?omianki, Poland
Bydgoszcz, Poland
Bydgoszcz, Poland
Bydgoszcz, Poland
Moskva, Moscow Oblast, Russia
Gauteng, South Africa
Germiston, South Africa
Kempton Park, South Africa
Polokwane, South Africa
Polokwane, South Africa
Pretoria, South Africa
Santiago de Compostela, LA Coruña, Spain
Madrid, Spain