UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012670
Receipt number R000014720
Scientific Title The Clinical and Virology effects of NA inhibitor in influenza virus infections (age;over 4 years old, under 13 years old):an open-label,randomized study Part 2.
Date of disclosure of the study information 2013/12/24
Last modified on 2019/01/30 13:42:51

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Basic information

Public title

The Clinical and Virology effects of NA inhibitor in influenza virus infections (age;over 4 years old, under 13 years old):an open-label,randomized study Part 2.

Acronym

The Clinical and Virology effects of NA inhibitor in influenza virus infections (age;over 4 years old, under 13 years old):an open-label,randomized study Part 2.

Scientific Title

The Clinical and Virology effects of NA inhibitor in influenza virus infections (age;over 4 years old, under 13 years old):an open-label,randomized study Part 2.

Scientific Title:Acronym

The Clinical and Virology effects of NA inhibitor in influenza virus infections (age;over 4 years old, under 13 years old):an open-label,randomized study Part 2.

Region

Japan


Condition

Condition

Childfood influenza infections

Classification by specialty

Medicine in general Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the clinical and virology effects of NA inhibitor on influenza virus (Sub-types;A/H1N1pdm2009,A/H3N2)and safty in childhood .

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

-Time to virus disappeared from the start of drug administration

Key secondary outcomes

-Time to return to normal body temperature (under 37.5 degrees)
-Time of flu symptoms to disappear
-The amount of change per unit time of the virus titer to the last observation time and day 3
-The drug sensitivity change for each NA inhibitor
-The time course and antibody titer
-Rate of relapse


Base

Study type

Interventional


Study design

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


Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Oseltamivir

Interventions/Control_2

Zanamivir

Interventions/Control_3

Peramivir

Interventions/Control_4

Laninamivir

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

4 years-old <=

Age-upper limit

13 years-old >

Gender

Male and Female

Key inclusion criteria

1) Age:over 4 years old, under 13 years old.
2) Patients or Guardian of the patients with informd consent.
3) Out Patient of febrile symptom.
4) The patient who consulted within 48 hours of fever with over 37.5 degrees.
5) A rapid antigen test of Influenza is positive (type A).

Key exclusion criteria

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

Target sample size

160


Research contact person

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


Public contact

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


Sponsor or person

Institute

Hirotsu Clinic

Institute

Department

Personal name



Funding Source

Organization

SHIONOGI&CO.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

SHIONOGI&CO.,LTD.

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

廣津医院(神奈川県)
渡辺クリニック(神奈川県)


Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 24 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

http://www.tandfonline.com/doi/pdf/10.1080/14787210.2018.1421945?needAccess=true

Number of participants that the trial has enrolled


Results

1st half of the study result (virus dynamics)were shown below:
http://www.tandfonline.com/doi/pdf/10.1080/14787210.2018.1421945?needAccess=true

2nd half of the study result (antibody dynamics) has been submitted (under review)

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

Completed

Date of protocol fixation

2013 Year 12 Month 09 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 17 Day

Last follow-up date

2015 Year 03 Month 28 Day

Date of closure to data entry

2015 Year 05 Month 11 Day

Date trial data considered complete

2015 Year 12 Month 10 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 12 Month 24 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=R000014720


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name