A Study to Assess the Safety, Pharmacokinetics (how the body affects the drug), and Efficacy (how well the drug works) of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients from Birth to < 1 Year with Influenza-Like Symptoms
- Conditions
- InfluenzaMedDRA version: 20.0 Level: LLT Classification code 10022001 Term: Influenza (epidemic) System Organ Class: 100000004862MedDRA version: 20.1 Level: LLT Classification code 10022003 Term: Influenza B virus infection System Organ Class: 100000004862MedDRA version: 20.1 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 100000004862MedDRA version: 20.0 Level: LLT Classification code 10016790 Term: Flu System Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2018-002154-70-ES
- Lead Sponsor
- Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 30
- Age from birth to < 1 year at screening
- Parent/guardian willing and able to comply with study requirements, in the investigator’s judgment
- Patients with a diagnosis of influenza virus infection confirmed by the presence of all of the following:
o Fever >= 38°C (tympanic temperature) at screening
o At least one respiratory symptom (either cough or coryza)
- The time interval between the onset of symptoms and screening is <= 96 hours
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
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
- 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)
- Weigh < 2.5 kg at screening
o Only children > 4.5 kg will be eligible to take part in countries that have volume limits for blood draws set at 1% of the total blood volume (maximum over 24 hour period) and 3% of the total blood volume (maximum over 30-day period)
- 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, hepatitis, cirrhosis, or pulmonary disease or patients with known chronic renal failure
- Active cancer at any site
- History of organ transplant
- Known allergy to study drug 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To evaluate the safety of a single dose of baloxavir marboxil;<br> Secondary Objective: • To evaluate the efficacy of baloxavir marboxil<br> • To evaluate the virological activity of baloxavir marboxil<br> • To evaluate the pharmacokinetics (PK) of baloxavir marboxil after single dose administration<br> ;Primary end point(s): 1. Incidence, severity, and timing of adverse events, serious adverse events, vital sign measurements, and clinical laboratory tests;Timepoint(s) of evaluation of this end point: 1. Up to Day 29 or early termination
- Secondary Outcome Measures
Name Time Method