UMIN-CTR Clinical Trial

Public title

Clinical and virological effects of NA inhibitors in pediatric patients with influenza B virus infection (between 4 years and 12 years old):an open-label,randomized study.

Acronym

Clinical and virological effects of NA inhibitors in pediatric patients with influenza B virus infection (between 4 years and 12 years old):an open-label,randomized study.

Scientific Title

Clinical and virological effects of NA inhibitors in pediatric patients with influenza B virus infection (between 4 years and 12 years old):an open-label,randomized study.

Scientific Title:Acronym

Clinical and virological effects of NA inhibitors in pediatric patients with influenza B virus infection (between 4 years and 12 years old):an open-label,randomized study.

Region

Japan

Condition

Pediatric patients with influenza B virus infection

Classification by specialty

Medicine in general

Pediatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the clinical and virological effects of NA inhibitors(peramivir, oseltamivir) on influenza B virus infection and safely in children. also to examine for the presence or absence of relapse.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Time to less than lower limit of quantification of virus titer from the start of drug treatment

Key secondary outcomes

*Time to return to normal body temperature (below 37.5 degrees)
*Time to resolution of flu symptoms
*Time-weighted change from baseline in the virus titer at day 3 and final observation time
*The drug sensitivity change for each NA inhibitor

*Rate of relapse

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Oseltamivir

Interventions/Control_2

Peramivir

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

4

years-old

<=

Age-upper limit

13

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Patients between 4 years and 12 years old.
2) Patients or guardian of the patients from whom obtained voluntary written informd consent.
3) Out patients with febrile symptom.
4) Patient who consulted within 48 hours after onset of fever over 37.5 degrees.
5) Patients who showed positive resut of rapid antigen test of Influenza B

Key exclusion criteria

1)History of hypersensitivity caused by neuraminidase inhibitors.
2)Patients with underlying disease as high risk factors that is likely to affect variation of virus.
3)Patients were deemed inappropriate for the study participants.

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Nobuo Hirotsu

Organization

Hirotsu Clinic

Division name

Internal Medicine, Pediatrics

Zip code

Address

Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki-shi, Kanagawa-ken, 231-0011, Japan

TEL

044-822-1933

Email

non-hirotsu@umin.ac.jp

Name of contact person

1st name
Middle name
Last name	Nobuo Hirotsu

Organization

Hirotsu Clinic

Division name

Internal Medicine, Pediatrics

Zip code

Address

Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki-shi, Kanagawa-ken, 231-0011, Japan

TEL

044-822-1933

Homepage URL

Email

non-hirotsu@umin.ac.jp

Institute

Hirotsu Clinic

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

02

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Suspended

Date of protocol fixation

2016

Year

02

Month

10

Day

Date of IRB

Anticipated trial start date

2016

Year

02

Month

16

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

02

Month

16

Day

Last modified on

2019

Year

01

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024282