UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007328
Receipt number R000008639
Scientific Title The clinical effects of peramivir on influenza virus infections in infants (age; over 28 days old, under 4 years old): an open-label,non-randomized, multi-centre study.
Date of disclosure of the study information 2012/02/21
Last modified on 2013/08/23 19:22:43

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Basic information

Public title

The clinical effects of peramivir on influenza virus infections in infants (age; over 28 days old, under 4 years old): an open-label,non-randomized, multi-centre study.

Acronym

The clinical effects of peramivir on influenza virus infections in infants (age; over 28 days old, under 4 years old).

Scientific Title

The clinical effects of peramivir on influenza virus infections in infants (age; over 28 days old, under 4 years old): an open-label,non-randomized, multi-centre study.

Scientific Title:Acronym

The clinical effects of peramivir on influenza virus infections in infants (age; over 28 days old, under 4 years old).

Region

Japan


Condition

Condition

Infants with Influenza virus 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 peramivir on influenza virus (Sub-types; A/H1N1pdm09, A/H3N2, B) in infants.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Time to return to normal body temperature (under 37.5 degrees).

Key secondary outcomes

Ratio of influenza virus-positive patients.
Virus mutation after treatment of peramivir.
Duration of influenza symptoms.


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 months-old <=

Age-upper limit

48 months-old >

Gender

Male and Female

Key inclusion criteria

Guardian of the patients with informed consent.
Gender: Male or female.
In patients or Out patients.
Age: over 28 days old, under 4 years old.
Patient who must be use to intravenous peramivir for the following: Can't use oral or inhaler medicines, dehydration, chronic diseases, severe symptoms, etc,.

Key exclusion criteria

History of hypersensitivity caused by neuraminidase inhibitors. Patients who are deemed to be inappropriate by the investigator.

Target sample size

48


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshio Takasaki

Organization

Takasaki Pediatric Clinic

Division name

Pediatrics

Zip code


Address

4-14-33 Shimoyamato, Nishi-ku, Fukuoka, 819-0052, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Takasaki Pediatric Clinic

Division name

Pediatrics

Zip code


Address

4-14-33 Shimoyamato, Nishi-ku, Fukuoka, 819-0052, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Takasaki Pediatric Clinic

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

高崎小児科医院(福岡県)、しんどう小児科医院(福岡県)、横山小児科医院(福岡県)、やました小児科医院(福岡県)


Other administrative information

Date of disclosure of the study information

2012 Year 02 Month 21 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

Completed

Date of protocol fixation

2012 Year 02 Month 10 Day

Date of IRB


Anticipated trial start date

2012 Year 02 Month 01 Day

Last follow-up date

2013 Year 06 Month 01 Day

Date of closure to data entry

2013 Year 07 Month 31 Day

Date trial data considered complete

2013 Year 09 Month 01 Day

Date analysis concluded

2013 Year 10 Month 15 Day


Other

Other related information

An open-label, non-randomized, multi-centre study.
Observe fever and symptoms.
Nasal/Throat swabs in fluid for virology.


Management information

Registered date

2012 Year 02 Month 19 Day

Last modified on

2013 Year 08 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008639


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name