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

• Status: Completed
• Trial end date: 2019-04-03
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, pharmacokinetics, and efficacy of baloxavir marboxil compared with oseltamivir in a single influenza episode in otherwise healthy pediatric participants (i.e., 1 to <12 years of age) with influenza-like symptoms.

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

Details

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

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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