NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-183882

Registered date:27/02/2018

Xofluza PMS

Basic Information

Recruitment status complete
Health condition(s) or Problem(s) studiedInfluenza A or B virus infection
Date of first enrollment14/3/2018
Target sample size3000
Countries of recruitmentJapan
Study typeOBSERVATIONAL
Intervention(s)Intervention name : Xofluza Tablets INN of the intervention : Baloxavir Marboxil Dosage And administration of the intervention : 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 intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -

Outcome(s)

Primary Outcomesafety, efficacy Safety, Efficacy
Secondary Outcomeother -

Key inclusion & exclusion criteria

Age minimum
Age maximum
GenderBOTH
Include criteriaInfluenza A or B virus infection patients
Exclude criteria-

Related Information

Contact

public contact
Name Shionogi &amp; Co., Ltd. Corporate Communications Department
Address http://www.shionogi.co.jp/en/company/outline/office.html
Telephone
E-mail
Affiliation
scientific contact
Name Shionogi &amp; Co., Ltd. Pharmacovigilance Department
Address 1-8, Doshomachi 3-Chome, Chuo-ku, Osaka 541-0045, Japan
Telephone +81-6-6209-6958
E-mail masakazu.notohara@shionogi.co.jp
Affiliation