UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024937 |
|---|---|
| Receipt number | 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 | 2020/11/24 09:36:37 |
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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 | Masaru |
| Middle name | |
| Last name | Miura |
Organization
Tokyo metropolitan children's medical center
Division name
cardiology
Zip code
1838561
Address
2-8-29 Musashidai, Fuchu city, Tokyo, Japan
TEL
042-300-5111
masaru10miura@gmail.com
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Miura |
Organization
Tokyo metropolitan children's medical center
Division name
cardiology
Zip code
1838561
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
masaru10miura@gmail.com
Sponsor or person
Institute
Tokyo metropolitan children's medical center
Institute
Department
Personal name
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
Tokyo Metropolitan Children's Medical Center
Address
2-8-29 Musashidai, Fuchu city, Tokyo, Japan
Tel
042-300-5111
sn_rinri@tmhp.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
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
| 2020 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028690
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
