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

Completed · Phase 3 · Has a placebo group

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT03629184

Run by

Hoffmann-La Roche

People needed

173

Starts

2018-11-20

Expected to finish

2019-04-03

Last updated by the study team

2020-04-29

Who can join

Age: 1 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Central Alabama Research; Pediatrics — Birmingham, Alabama, United States
• Harrisburg Family Medical Center — Harrisburg, Arkansas, United States
• The Children's Clinic of Jonesboro, P.A. — Jonesboro, Arkansas, United States
• The Probe Medical Research — Los Angeles, California, United States
• Orange County Research Institute — Ontario, California, United States
• Khruz Biotechnology Research Institute — San Diego, California, United States
• Avanza Medical Research Center — Pensacola, Florida, United States
• Clinical Research Prime — Idaho Falls, Idaho, United States
• Cotton O'Neil Clinic; Stormont-Vail Hlth Care — Topeka, Kansas, United States
• Kentucky Pediatric Research Center — Bardstown, Kentucky, United States
• Spiegel, Craig — Bridgeton, Missouri, United States
• Meridian Clinical Research, Llc — Omaha, Nebraska, United States
• Machuca Family Medicine — Las Vegas, Nevada, United States
• OnSite Clinical Solutions LLC — Charlotte, North Carolina, United States
• Montgomery Medical Research /Frontier Clinical Research — Smithfield, North Carolina, United States
• Ohio Pediatric Research Association — Dayton, Ohio, United States
• Coastal Pediatric Research — Charleston, South Carolina, United States
• AFC Urgent Care- Cleveland — Cleveland, Tennessee, United States
• Holston Medical Group — Kingsport, Tennessee, United States
• Oak Cliff Research Company, LLC — Dallas, Texas, United States
• HD Research Corp — Houston, Texas, United States
• Mercury Clinical Research — Houston, Texas, United States
• Tekton Research — San Antonio, Texas, United States
• DM Clinical Research — Tomball, Texas, United States
• ClinPoint Trials — Waxahachie, Texas, United States

Full record on ClinicalTrials.gov

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