UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038159 |
|---|---|
| Receipt number | R000043500 |
| Scientific Title | Comparison on the prevention of severe influenza between baloxavir marboxil and neuraminidase inhibitors using health insurance claims database -2018/2019 influenza season- |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2021/01/20 15:56:14 |
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Basic information
Public title
Comparison on the prevention of severe influenza between baloxavir marboxil and neuraminidase inhibitors using health insurance claims database -2018/2019 influenza season-
Acronym
Comparison on the prevention of severe influenza between baloxavir marboxil and neuraminidase inhibitors using health insurance claims database
Scientific Title
Comparison on the prevention of severe influenza between baloxavir marboxil and neuraminidase inhibitors using health insurance claims database -2018/2019 influenza season-
Scientific Title:Acronym
Comparison on the prevention of severe influenza between baloxavir marboxil and neuraminidase inhibitors using health insurance claims database
Region
| Japan |
Condition
Condition
Influenza virus infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the preventive effect of baloxavir marboxil on severe influenza compared with neuraminidase inhibitors in 2018/2019 influenza season. The primary comparison group is patients who were prescribed oseltamivir.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of hospitalization
Key secondary outcomes
Occurrence of administration of antibiotics, occurrence of pneumonia, occurrence of additional administration of anti-influenza drugs
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
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients whose first diagnosis date for influenza (Day 1) was within the enrollment period (1 Oct 2018 - 17 Apr 2019)
2)Patients who were continuously registered in the database for at least 6 months before Day 1
3)Patients who received baloxavir marboxil, oseltamivir, zanamivir or laninamivir on Day 1
Key exclusion criteria
1)Patients who were hospitalized on Day 1 or in the last 90 days before Day 1
2)Patients who received antibiotics on Day 1 or in the last 90 days before Day 1
3)Patients who were diagnosed as pneumonia in the last 3 months before Day 1
4)Patients who died on Day 1
5)Patients who were less than 1 year old on Day 1
6)Patients who received several anti-influenza drugs on Day 1
Target sample size
130000
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Masaru 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 | Masakazu |
| Middle name | |
| Last name | Notohara |
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
+81-6-6209-6958
Homepage URL
masakazu.notohara@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
N/A
Address
N/A
Tel
N/A
N/A
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
| 2019 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciaa1870/6044623
Number of participants that the trial has enrolled
339007
Results
please refer described below:
https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciaa1870/6044623
Results date posted
| 2021 | Year | 01 | Month | 20 | Day |
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
Main results already published
Date of protocol fixation
| 2019 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2019 | Year | 09 | Month | 30 | Day |
Last modified on
| 2021 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043500
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
