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

NCT03629184

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Influenza

Interventions: Baloxavir Marboxil, Oseltamivir

Countries: United States, Costa Rica, Israel, Mexico, Poland, Russia, Spain

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.

Eligibility overview

Sex: ALL

Age: 1 Year to 11 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (37)

Birmingham, Alabama, United States
Harrisburg, Arkansas, United States
Jonesboro, Arkansas, United States
Los Angeles, California, United States
Ontario, California, United States
San Diego, California, United States
Pensacola, Florida, United States
Idaho Falls, Idaho, United States
Topeka, Kansas, United States
Bardstown, Kentucky, United States
Bridgeton, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Charlotte, North Carolina, United States
Smithfield, North Carolina, United States
Dayton, Ohio, United States
Charleston, South Carolina, United States
Cleveland, Tennessee, United States
Kingsport, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Tomball, Texas, United States
Waxahachie, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
San José, Costa Rica
Petah Tikva, Israel
Monterrey, N.L, Mexico
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