UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035028
Receipt number R000039927
Scientific Title Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study
Date of disclosure of the study information 2018/11/27
Last modified on 2020/05/10 14:16:18

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Basic information

Public title

Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study

Acronym

Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study

Scientific Title

Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study

Scientific Title:Acronym

Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study

Region

Japan


Condition

Condition

Influenza

Classification by specialty

Infectious disease Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare Baloxavir marboxil, Oseltamivir and Laninamivir with efficacy and safety in pediatric patients with influenza.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The time to resolution of fever

Key secondary outcomes

The number of days absent from school or preschool
The number of asthmatic symptoms
The number of pneumonia
The number of gastrointestinal symptoms
The number of abnormal behaviors
Drug adherence


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Baloxavir marboxil

Interventions/Control_2

Oseltamivir

Interventions/Control_3

Laninamivir

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

15 years-old >=

Gender

Male and Female

Key inclusion criteria

1)A positive rapid antigen test for influenza is required
2)Fever >=38 degree (axillary) in the pre-dose examination
3)Body weight more than 10kg

Key exclusion criteria

1)Patients or their parents do not accept the assigned drug
2)A symptom duration of more than 48 hours
3)Patients who have any chronic respiratory disease, cardiovascular disease, central nervous disorder, immune dysfunction, or other chronic comorbid condition except asthma
4)Patients with severe influenza virus infection requiring inpatient treatment

Target sample size

600


Research contact person

Name of lead principal investigator

1st name Hisato
Middle name
Last name Ito

Organization

Kyoto Chubu Medical Center

Division name

Department of Pediatrics

Zip code

629-0197

Address

25 Yagiueno Yagimachi Nantanshi Kyoto Japan

TEL

+81-771-42-2510

Email

hisato527@leto.eonet.ne.jp


Public contact

Name of contact person

1st name Masaya
Middle name
Last name Suematsu

Organization

Kyoto Chubu Medical Center

Division name

Department of Pediatrics

Zip code

629-0197

Address

25 Yagiueno Yagimachi Nantanshi Kyoto Japan

TEL

+81-771-42-2510

Homepage URL


Email

masa16@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Chubu Medical Center
Department of Pediatrics

Institute

Department

Personal name



Funding Source

Organization

Kyoto Chubu Medical Center
Department of Pediatrics

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Saiseikai Kyoto Hospital
Matsui Pediatrics Clinic
Sato Clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto Chubu Medical Center

Address

25 Yagiueno Yagimachi Nantanshi Kyoto Japan

Tel

+81-771-42-2510

Email

masa16@koto.kpu-m.ac.jp


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

2018 Year 11 Month 27 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

368

Results

The efficacy of baloxavir marboxil was similar to that of NAIs, and there was no difference in side effects.

Results date posted

2020 Year 05 Month 10 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

No longer recruiting

Date of protocol fixation

2018 Year 11 Month 27 Day

Date of IRB

2018 Year 11 Month 01 Day

Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date

2019 Year 05 Month 31 Day

Date of closure to data entry

2020 Year 12 Month 31 Day

Date trial data considered complete

2020 Year 12 Month 31 Day

Date analysis concluded

2020 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 11 Month 27 Day

Last modified on

2020 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039927


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name