臨床研究等提出・公開システム

An Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Baloxavir Marboxil 2% Granules after Administration of a Single Dose to Otherwise Healthy Pediatric Patients with Influenza

A Open-label Study of Baloxavir Marboxil Granules in Otherwise Healthy Pediatric Patients With Influenza

45

In the ITTI population, the mean age was 2.8 years. The population consisted of 24 male (55.8%) and 19 female (44.2%) patients. The mean body weight (SD) was 13.76 (3.47) kg. The most common influenza virus strain was subtype A/H3 (51.2%), followed by subtype A/H1N1pdm and subtype B (both 23.3%), and mixed infection (2.3%).

Forty-five patients enrolled into the study and all of the patients completed the study.

No deaths, serious adverse events, or adverse events leading to withdrawal were reported in the study.

AEs were reported in 24 of 45 patients (53.3%, 38 events). Treatment-related AEs were reported in 3 of 45 patients (6.7%, 3 events). All AEs were classified as Grade 1 or 2. All AEs classified as Grade 2 were considered not to be related to the study drug.

The median time to alleviation of influenza illness (95% CI) was 37.8 (27.5, 46.7) hours in the ITTI population. The results of the PPS were comparable to those of the ITTI population.

S-033188 2% granules were considered to be well tolerated and effective in pediatric patients with influenza virus infection who weighed less than 20 kg at higher doses than those administered in the previous studies in Japanese pediatric patients.

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

https://www.clinicaltrials.jp/file/WVArthLbd

Shionogi & Co., Ltd.

shionogiclintrials-admin@shionogi.co.jp

Shionogi & Co., Ltd.

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

completed

Jan. 21, 2019

Interventional

Open-label, non-controlled

treatment purpose

3

- Patients confirmed with influenza virus infection and within 48 hours from onset.
- Patients whose body weight is less than 20 kg.
etc.

-Patients with severe symptoms of influenza virus infection requiring inpatient treatment.
- Patients with high risk factors.
- Patients with concurrent infections requiring systemic antimicrobial and/or antiviral therapy.
etc.

Both

Influenza A and/or B virus infection

investigational material(s)
Generic name etc : baloxavir marboxil
INN of investigational material : baloxavir marboxil
Therapeutic category code : 625 Anti-virus agents
Dosage and Administration for Investigational material : oral

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
Percentage of patients with any adverse events, etc.

efficacy
pharmacokinetics
time to alleviation of influenza illness, etc.

Jan. 10, 2019