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

Completed · Phase 3

Conditions studied: Influenza

In brief

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

Key facts

Study ID

NCT03653364

Run by

Hoffmann-La Roche

People needed

49

Starts

2019-01-23

Expected to finish

2023-04-03

Last updated by the study team

2024-05-17

Who can join

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

You may qualify if…

• 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:
• In the investigator's judgement there is a clinical suspicion of influenza
• 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)

You may not qualify if…

• 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

Where it is running

• The Children's Clinic of Jonesboro, P.A. — Jonesboro, Arkansas, United States
• Usf Health — Tampa, Florida, United States
• Clinical Research Prime — Idaho Falls, Idaho, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago;Division of Infectious Disease — Chicago, Illinois, United States
• Kentucky Pediatric Research Center — Bardstown, Kentucky, United States
• Oak Cliff Research Company, LLC — Dallas, Texas, United States
• Mercury Clinical Research — Houston, Texas, United States
• Tekton Research — San Antonio, Texas, United States
• MHAT Stamen Iliev AD — Montana, Bulgaria
• SHAT for Pneumo-Phtysiatric Diseases ?Dr. Dimitar Gramatikov?; Dept. of Pulmonology and Phtisiatrics — Rousse, Bulgaria
• ICIMED Instituto de Investigación en Ciencias Médicas — San José, Costa Rica
• TAYS Lastenklinikka; Lasten lääketutkimuskeskus Peetu — Tampere, Finland
• Clalit Health Services- Pediatric Ambulatory Clinic; Pediatric Ambulatory Clinic — Petah Tikva, Israel
• NZOZ Salmed — ??czna, Poland
• Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Lesnym — ?omianki, Poland
• Wojewodzki Szpital Obserwacyjno-Zakazny; Oddzia? Pediatrii, Chorób Infekcyjnych i Hepatologii — Bydgoszcz, Poland
• IN VIVO Sp. z o.o. — Bydgoszcz, Poland
• NZOZ Vitamed — Bydgoszcz, Poland
• The scientific-research institute of epidemiology; Infectious clinical hospital ?2 of Moscow H.D. — Moskva, Moscow Oblast, Russia
• Global Clinical Trials; Clinical Trials — Gauteng, South Africa
• GAMA; Clinical Research — Germiston, South Africa
• Peermed Clinical Trial Centre — Kempton Park, South Africa
• Metropolitan Clinical Research Institute — Polokwane, South Africa
• Pholosho Netcare; Netcare Hospital — Polokwane, South Africa
• Setshaba Research Centre; Clinical Research — Pretoria, South Africa

Full record on ClinicalTrials.gov

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