Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms
NCT ID: NCT03653364
Last Updated: 2024-05-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
49 participants
INTERVENTIONAL
2019-01-23
2023-04-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Baloxavir Marboxil
Participants will receive single oral dose of baloxavir marboxil on Day 1 (based on body weight and age).
Baloxavir Marboxil
Participants will receive single oral dose of baloxavir marboxil on Day 1 based on body weight and age. Participants aged ≥ 3 months to \<12 months old received baloxavir marboxil, 2 milligrams per kilograms (mg/kg). Participants from birth to \< 4 weeks old and ≥ 4 weeks to \< 3 months old received baloxavir marboxil, 1 mg/kg.
Interventions
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Baloxavir Marboxil
Participants will receive single oral dose of baloxavir marboxil on Day 1 based on body weight and age. Participants aged ≥ 3 months to \<12 months old received baloxavir marboxil, 2 milligrams per kilograms (mg/kg). Participants from birth to \< 4 weeks old and ≥ 4 weeks to \< 3 months old received baloxavir marboxil, 1 mg/kg.
Eligibility Criteria
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Inclusion Criteria
* 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:
1. In the investigator's judgement there is a clinical suspicion of influenza
2. 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)
Exclusion Criteria
* 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
1 Year
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Locations
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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
Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría
Santiago de Compostela, LA Coruña, Spain
Hospital Universitario 12 de Octubre; Servicio de Pediatria
Madrid, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-002154-70
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CP40559
Identifier Type: -
Identifier Source: org_study_id
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