Xofluza PMS

JRCT ID: jRCT1080223826

Registered date:27/02/2018

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Influenza A or B virus infection
• Date of first enrollment: 27/02/2018
• Target sample size: 3000
• Countries of recruitment: Japan
• Study type: Observational

Intervention(s)

investigational material(s)
Generic name etc : Xofluza Tablets
INN of investigational material : Baloxavir Marboxil
Therapeutic category code : 625 Anti-virus agents
Dosage and Administration for Investigational material : 1.Usually for adults and children 12 years of age or older, administer two XOFLUZA 20-mg tablets as a single oral dose. For patients weighing 80 kg or more, however, administer four XOFLUZA 20-mg tablets as a single oral dose. 2. Usually for children less than 12 years of age, XOFLUZA should be administered as a single oral dose at the following doses. (Body weight >=40 kg : Two 20-mg tablets, Body weight >=20 kg to <40 kg : One 20-mg tablet, Body weight >=10 kg to <20 kg : One 10-mg tablet)

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

Outcome(s)

Primary Outcome

safety
efficacy
Safety, Efficacy

Secondary Outcome

other
-

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Influenza A or B virus infection patients
• Exclude criteria: -

Related Information

• Primary Sponsor: SHIONOGI & CO., LTD.
• Secondary Sponsor: -
• Source(s) of Monetary Support: SHIONOGI &amp; CO., LTD.
• Secondary ID(s): JapicCTI-183882