Influenza
Conditions
Interventions
Trade Name: Xofluza
Product Name: Baloxavir Marboxil
Pharmaceutical Form: Granules in sachet
INN or Proposed INN: BALOXAVIR MARBOXIL
Current Sponsor code: S-033188
Other descriptive name: RO7191686
Sponsors
Shionogi & Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients whose body weight at Screening is less than 20 kg and aged less than 12 years when informed consent obtained from the patient’s parent/legally acceptable representative and/or informed assent obtained, as appropriate to the age of patient. If the patient is younger than 1 year of age, he/she had to have body weight no less than 2500 g at birth. - Patients with a diagnosis of influenza virus infection confirmed by all of the following: fever =/> 38 C (axillary temperature) at Screening visit and positive rapid influenza diagnostic test (RIDT) by nasopharyngeal (if difficult, nasal or throat) swabs. - Patients with onset of symptoms within 48 hours at the time of informed consent. 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
Exclusion criteria
Exclusion criteria: - Patients with severe symptoms of influenza virus infection requiring inpatient treatment. - Patients with any of the following high risk factors: chronic respiratory diseases, neurological and neurodevelopmental disorders, heart disease, blood disorders, endocrine disorders, kidney disorders, liver disorders, metabolic disorders, compromised immune system. - Patients with any disturbance of consciousness, abnormal behavior or convulsions at Screening, or with a current condition of encephalitis or encephalopathy. - Patients with history of encephalitis, encephalopathy, epilepsy, or influenza virus infection associated abnormal behavior within the past 2 years. - Patients with concurrent infections requiring systemic antimicrobial and/or antiviral therapy at Screening. - Patients who have received baloxavir marboxil (Xofluza®), peramivir (Rapiacta®), laninamivir (Inavir®), oseltamivir (Tamiflu®), zanamivir (Relenza®) or amantadine (Symmetrel®) within 30 days prior to Screening (including prophylaxis). - Patient with known allergy and/or history of significant intolerance against baloxavir marboxil and/or acetaminophen. - Patients with severe underlying diseases. - Patients who have been exposed to an investigational drug within 30 days or 5 half-lives of the drug prior to Screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the efficacy of baloxavir marboxil 2% granules in otherwise healthy pediatric subjects weighing less than 20 kg with influenza virus infection. - To assess the safety and tolerability of a single dose of baloxavir marboxil 2% granules in pediatric patients weighing less than 20 kg. -To assess the pharmacokinetics (PK) of S-033447, the active form of S-033188 (baloxavir marboxil), after single dose administration of baloxavir marboxil 2% granules in pediatric patients weighing less than 20 kg. ;Secondary Objective: Not applicable;Primary end point(s): Time to alleviation of influenza illness;Timepoint(s) of evaluation of this end point: Day 1 through Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Influenza virus titer 2) Amount of virus RNA (reverse transcription polymerase chain reaction [RT-PCR]) 3) Change from baseline in influenza virus titer 4) Change from baseline in the amount of virus RNA (RT-PCR) 5) Percentage of participants positive for influenza virus titer 6) Percentage of participants positive by RT-PCR 7) Area under the curve in virus titer 8) Area under the curve in the amount of virus RNA (RT-PCR) 9) Time to cessation of viral shedding by virus titer 10) Time to cessation of viral shedding by RT-PCR 11) Time to resolution of fever 12) Percentage of participants reporting normal temperature 13) Body temperature 14) Time to alleviation of individual symptoms 15) Time to resumption of normal activity 16) Percentage of participants of influenza-related complications 17) Percentage of participants of influenza-related complications particularly seen in pediatric patients 18) Plasma concentrations of S-033447 19) Percentage of participants with adverse events ;Timepoint(s) of evaluation of this end point: 1-6) Predose on Day 1, Days 2, 3, 4 (one visit on either Day 3 or Day 4 is mandatory), 6, 9; if flu symptoms persist: on Days 15, 22 7-10) Day 1 up to Day 22 11) Day 1 up to Day 14 12-13) Predose on Day 1 up to Day 14 14-15) Day 1 up to Day 14 16-17) Predose on Day 1 up to Day 22 18) 0.5 to 2 hours postdose on Day 1, Day 2, at one time point during the period from Day 6 to 22, and at Day 3 and/or Day 4 as needed 19) Day 1 up to Day 22 | — |
Countries
Japan
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd.
Outcome results
None listed