UMIN-ICDS Clinical Trial

Unique ID issued by UMIN	UMIN000051382
Receipt number	R000058469
Scientific Title	Comparison of hospitalization incidence in type B influenza outpatients treated with baloxavir marboxil or oseltamivir phosphate in 2018/2019 and 2019/2020 influenza season using insurance claim database
Date of disclosure of the study information	2023/06/20
Last modified on	2023/06/19 18:58:25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information

Public title

Comparison of hospitalization incidence in type B influenza outpatients treated with baloxavir marboxil or oseltamivir phosphate in 2018/2019 and 2019/2020 influenza season using insurance claim database

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Type B Influenza virus infection

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Hospitalization incidence (days 2-14) with the date of diagnosis of influenza B virus infection as Day 1

Key secondary outcomes

Incidence of each of the following events from Day 2 to Day 14
-Administration of antibiotic injection
-Pneumonia diagnosis
-Additional administration of anti-influenza drugs
-Administration of antibiotic injection with pneumonia
-Oxygen inhalation with pneumonia
-Hospitalization with pneumonia
-Hospitalization with heart failure
-Hospitalization with pneumonia
-Hospitalization with heart failure

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 with the first diagnosis date of influenza B virus infection during October 1, 2018 to April 17, 2019 or October 1, 2019 to April 17, 2020 and who have 6 months look-back period prior to the diagnosis day (Day 1)
2, Patients who were prescribed baloxavir marboxil or oseltamivir phosphate on Day 1

Key exclusion criteria

1, Prescribed antibacterial agents (ATC middle classification code : J01) on Day 1
2, Diagnosed with pneumonia (ICD-10 code J12-J18) on Day 1
3, Died on Day 1
4, Under 1 year old on Day 1
5, Prescribed multiple anti-influenza drug on Day 1
6, Hospitalized on Day 1

Target sample size

15000

Research contact person

Name of lead principal investigator

1st name Takahiro

Middle name

Last name Takazono

Organization

Nagasaki University Hospital

Division name

Respiratory Medicine

Zip code

852-8501

Address

1-7-1 Sakamoto, Nagasaki-shi, Nagasaki

TEL

095-819-7200

Email

takahiro-takazono@nagasaki-u.ac.jp

Public contact

Name of contact person

1st name Genta

Middle name

Last name Ito

Organization

Shionogi & Co., Ltd.

Division name

Data Science Department

Zip code

541-0047

Address

4F, Midosuji MTR Building, 6-3, Awajimachi 3-chome, Chuo-ku, Osaka-shi, Osaka

TEL

070-7812-6266

Homepage URL

Email

genta.ito@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

Address

Tel

9999999

Email

XXXX@XXXX

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2023 Year 06 Month 20 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

2023 Year 06 Month 02 Day

Date of IRB

Anticipated trial start date

2023 Year 06 Month 02 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2023 Year 06 Month 19 Day

Last modified on

2023 Year 06 Month 19 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058469

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name