UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060194 |
|---|---|
| Receipt number | R000068849 |
| Scientific Title | XOFLUZA Granules 2% Individual Packets Specified Drug Use results Survey(Survey of patients weighing less than 10 kg) |
| Date of disclosure of the study information | 2026/01/05 |
| Last modified on | 2025/12/24 18:06:40 |
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Basic information
Public title
XOFLUZA Granules 2% Individual Packets Specified Drug Use results Survey (Survey of patients weighing less than 10 kg)
Acronym
XOFLUZA Granules Specified Drug Use results Survey(Survey of patients weighing less than 10 kg)
Scientific Title
XOFLUZA Granules 2% Individual Packets Specified Drug Use results Survey(Survey of patients weighing less than 10 kg)
Scientific Title:Acronym
XOFLUZA Granules Specified Drug Use results Survey(Survey of patients weighing less than 10 kg)
Region
| Japan |
Condition
Condition
influenza A or B virus infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect the safety and the efficacy of XOFLUZA Granules in patients weighing less than 10 kg under actual use conditions
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety in patients weighing less than 10 kg
Key secondary outcomes
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
Patients with influenza A or B virus infection weighing less than 10 kg who are receiving baloxavir marboxil for the first time
Key exclusion criteria
NA
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Niimi |
Organization
Shionogi & Co., Ltd.
Division name
Pharmacovigilance Department
Zip code
530-0011
Address
GRAND GREEN OSAKA South Building Park Tower, 5-54 Ofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL
+81-6-6202-2161
yuka.niimi@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
530-0011
Address
GRAND GREEN OSAKA South Building Park Tower, 5-54 Ofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL
+81-6-6202-2161
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
| 2026 | Year | 01 | Month | 05 | 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
| 2025 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Post marketing special drug use results survey, IRB information not necessary
Management information
Registered date
| 2025 | Year | 12 | Month | 24 | Day |
Last modified on
| 2025 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068849
