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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024937
Receipt No. R000028690
Scientific Title Prospective Study on Efficacy of Acute Treatment in a Multicenter Cohort of Children with Kawasaki Disease
Date of disclosure of the study information 2016/11/21
Last modified on 2018/11/25

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Basic information
Public title Prospective Study on Efficacy of Acute Treatment in a Multicenter Cohort of Children with Kawasaki Disease
Acronym PEACOCK
Scientific Title Prospective Study on Efficacy of Acute Treatment in a Multicenter Cohort of Children with Kawasaki Disease
Scientific Title:Acronym PEACOCK
Region
Japan

Condition
Condition Kawasaki disease
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the efficacy and safety of treatment of acute Kawasaki disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of coronary artery lesions at month 1 after stating initial treatment
Key secondary outcomes incidence of additional rescue treatment

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients diagnosed as Kawasaki disease according to the Japanese diagnostic criteria for Kawasaki disease
Key exclusion criteria patients who were treated at other hospitals and then transferred to our study group hospitals
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Miura
Organization Tokyo metropolitan children's medical center
Division name cardiology
Zip code
Address 2-8-29 Musashidai, Fuchu city, Tokyo, Japan
TEL 042-300-5111
Email masaru_miura@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Miyata
Organization Tokyo metropolitan children's medical center
Division name cardiology
Zip code
Address 2-8-29 Musashidai, Fuchu city, Tokyo, Japan
TEL 042-300-5111
Homepage URL http://www.byouin.metro.tokyo.jp/shouni/tiken/rinshou_shounin.html
Email koichi_miyata@tmhp.jp

Sponsor
Institute Tokyo metropolitan children's medical center
Institute
Department

Funding Source
Organization Tokyo metropolitan government
Organization
Division
Category of Funding Organization Local Government
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 東京都立小児総合医療センター / Tokyo metropolitan children's medical center

Other administrative information
Date of disclosure of the study information
2016 Year 11 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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing particular

Management information
Registered date
2016 Year 11 Month 21 Day
Last modified on
2018 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028690

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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