A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients 1 to <12 Years of Age with Influenza-Like Symptoms
- Conditions
- Therapeutic area: Diseases [C] - Virus Diseases [C02]MedDRA version: 20.1 Level: LLT Classification code 10022003 Term: Influenza B virus infection System Organ Class: 100000004862MedDRA version: 20.0 Level: LLT Classification code 10016790 Term: Flu System Organ Class: 100000004862MedDRA version: 20.0 Level: LLT Classification code 10022001 Term: Influenza (epidemic) System Organ Class: 100000004862MedDRA version: 20.1 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 100000004862Influenza
- Registration Number
- EUCTR2018-002169-21-ES
- Lead Sponsor
- Roche Farma SA que realiza un el ensayo en España y que actúa como representante de F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 173
- Aged 1 to < 12 years at randomization (Day 1)
- Parent/guardian willing and able to comply with study requirements, in the investigator’s judgment
- Patient able to comply with study requirements, depending on the patient’s level of understanding
- Patient with a diagnosis of influenza virus infection confirmed by the presence of all of the following:
? Fever >=38 degrees C (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 (the onset of symptoms is defined as the time when body temperature first exceeded 37.5 degrees C if known, or the time when the first symptom was noticed by patient, parent or caregiver)
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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 patients 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 who have commenced menarche (i.e., child-bearing potential)
- Participation in a clinical trial within 4 weeks or 5 half-lives of exposure to an investigational drug prior to screening, whichever is longer
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To compare the safety of a single dose of baloxavir marboxil with 5 days of oseltamivir administered twice daily;<br> Secondary Objective: • To evaluate the PK of baloxavir marboxil and baloxavir after single dose of baloxavir marboxil<br> • To evaluate the clinical efficacy of baloxavir marboxil compared with oseltamivir<br> • To evaluate the antiviral activity of baloxavir marboxil compared with oseltamivir<br> ;Primary end point(s): Incidence, severity, and timing of adverse events, serious adverse events, vital sign measurements, and clinical laboratory test results;Timepoint(s) of evaluation of this end point: Up to Day 29
- Secondary Outcome Measures
Name Time Method