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

• Status: Recruiting
• Trial end date: 2022-08-02
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Baloxavir

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:

• Fever ≥ 38°C (tympanic temperature) at screening or within the 4 hours prior if antipyretics were taken.

• At least one respiratory symptom (either cough or coryza)

• Positive prescreening influenza test (RIDT or PCR) performed within 24 hours of screening

• Participants with a negative prescreening COVID-19 test (PCR)

• 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