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Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms
- Infectious Diseases
- Influenza
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:
Completed
This study runs in
Cities
- Bardstown
- Bydgoszcz
- Chicago
- Dallas
- Dziekanów Leśny
- Germiston
- Houston
- Idaho Falls
- Jonesboro
- Kempton Park
- Madrid
- Montana
- Petah Tikva
- Polokwane
- Pretoria
- Ruse
- San Antonio
- San José
- Santiago de Compostela
- Soshanguve
- Tampa
- Tampere
- therapeutica
- Łęczna
Trial Identifier:
NCT03653364 2018-002154-70 CP40559
The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
Study Summary
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
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT03653364, CP40559, 2018-002154-70
Trial Identifier
Baloxavir Marboxil
Treatments
Influenza
Condition
Official Title
A Multicenter, Single-Arm, Open-Label Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients From Birth to < 1 Year With Influenza-Like Symptoms
Eligibility Criteria
All
Gender
≤ 1 Year
Age
No
Healthy Volunteers
Inclusion Criteria
- 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 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
- 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
For the latest version of this information please go to www.forpatients.roche.com