UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042673 |
|---|---|
| Receipt number | 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 | 2025/06/11 12:30:08 |
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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
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
kanae.hara@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2045 | Year | 12 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Non-comparative, open-label survey
This study is a survey of actual baloxavir usage under the GPSP ministerial ordinance, so "ethics committee approval" are not required.
Management information
Registered date
| 2020 | Year | 12 | Month | 07 | Day |
Last modified on
| 2025 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048690
