UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038155
Receipt number R000043498
Scientific Title Comparison on the prevention of household influenza infection 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 15:55:29

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Basic information

Public title

Comparison on the prevention of household influenza infection between baloxavir marboxil and neuraminidase inhibitors using health insurance claims database -2018/2019 influenza season-

Acronym

Comparison on the prevention of household influenza infection between baloxavir marboxil and neuraminidase inhibitors using health insurance claims database

Scientific Title

Comparison on the prevention of household influenza infection between baloxavir marboxil and neuraminidase inhibitors using health insurance claims database -2018/2019 influenza season-

Scientific Title:Acronym

Comparison on the prevention of household influenza infection 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 household influenza infection compared with neuraminidase inhibitors in 2018/2019 influenza season. The primary comparison drug is oseltamivir.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Occurrence of household influenza infection

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

1)Families which had an IC (index case; the first patient diagnosed as influenza in each family) during the enrollment period (1 Oct 2018 - 23 Apr 2019)
2)Families whose IC was an outpatient
3)Families whose IC received baloxavir marboxil, oseltamivir, zanamivir or laninamivir on Day 1 (the first date when an IC was diagnosed as influenza).

Key exclusion criteria

1)Families in which no family member was identified other than the IC
2)Families which had two or more ICs
3)Families whose IC was hospitalized after outpatient diagnosis
4)Families whose IC received several anti-influenza drugs

Target sample size

120000


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 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


Email

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

Email

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/ciaa1622/5939856

Number of participants that the trial has enrolled

208225

Results

please refer described below:
https://academic.oup.com/cid/advance-article-abstract/doi/10.1093/cid/ciaa1622/5939856

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 01 Month 31 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=R000043498


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name