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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042673
Receipt No. R000048690
Scientific Title XOFLUZA Specified Drug Use-results Survey (high-risk subjects in prophylaxis use)
Date of disclosure of the study information 2020/12/25
Last modified on 2020/12/07

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Basic information
Public title XOFLUZA Specified Drug Use-results Survey (high-risk subjects in prophylaxis use)
Acronym XOFLUZA Specified Drug Use-results Survey (high-risk subjects in prophylaxis use)
Scientific Title XOFLUZA Specified Drug Use-results Survey (high-risk subjects in prophylaxis use)
Scientific Title:Acronym XOFLUZA Specified Drug Use-results Survey (high-risk subjects in prophylaxis use)
Region
Japan

Condition
Condition Prophylaxis for influenza virus infection
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the safety for household members at specific high-risk in prophylaxis use of XOFLUZA
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Incidence rates of adverse drug reactions for household members at specific high-risk of XOFLUZA in prophylaxis use
Key secondary outcomes Prevalence rates of influenza virus infections for household members at specific high-risk of XOFLUZA in prophylaxis use

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Household members at specific high-risk who live with an influenza-infected index patient
Key exclusion criteria NA
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Masaru
Middle name
Last name Sawada
Organization Shionogi & Co., Ltd.
Division name Pharmacovigilance Department
Zip code 541-0045
Address 1-8, Doshomachi 3-Chome, Chuo-ku, Osaka 541-0045, Japan
TEL +81-6-6209-6974
Email masaru.sawada@shionogi.co.jp

Public contact
Name of contact person
1st name Kanae
Middle name
Last name Hara
Organization Shionogi & Co., Ltd.
Division name Pharmacovigilance Department
Zip code 541-0045
Address 1-8, Doshomachi 3-Chome, Chuo-ku, Osaka 541-0045, Japan
TEL +81-6-6209-6974
Homepage URL
Email kanae.hara@shionogi.co.jp

Sponsor
Institute Shionogi & Co., Ltd.
Institute
Department

Funding Source
Organization Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization NA
Address NA
Tel NA
Email NA

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Basic design: Non-comparative, open-label survey

Management information
Registered date
2020 Year 12 Month 07 Day
Last modified on
2020 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048690

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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