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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000683
Receipt No. R000000819
Scientific Title Infliximab open labeled trial of efficacy and safty against intractable Kawasaki disease
Date of disclosure of the study information 2007/05/01
Last modified on 2007/04/18

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Basic information
Public title Infliximab open labeled trial of efficacy and safty against intractable Kawasaki disease
Acronym Infliximab open labeled trial against intractable Kawasaki disease
Scientific Title Infliximab open labeled trial of efficacy and safty against intractable Kawasaki disease
Scientific Title:Acronym Infliximab open labeled trial against intractable Kawasaki disease
Region
Japan

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

Objectives
Narrative objectives1 To confirm efficacy and safty of infliximab against intractable Kawasaki disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Development coronary lesion at 4 weeks after treatment
Key secondary outcomes Improvement of fever and inflammatory finding at 7 days and 4 weeks after treatment

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The example of the Kawasaki disease that is not improved in gamma globulin treatment is made a contrast group, and the infliximab of 5 mg/kg is administered in the single time vein from July 1, 2005 to June 30, 2007.
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
2 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The improvement of the inflammation examination opinion such as clinical conditions, CRP and fever is not admitted by the IVGG treatment (4g/kg or less) among examples of the Kawasaki disease diagnosed by the Kawasaki's disease diagnosis standard of the Ministry of Health, Labour and Welfare. The case who can have received agreement from parents or the legal parental authority person by the document further in the example of the obstinacy syndrome of two years old or more of not finding abnormality in the cardiac function is targeted.
Key exclusion criteria Case who shows clear state of infectious disease.
Example of decline of cardiac function (EF 65% or less) syndrome.
Case who showed allergic reaction against infliximab before.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Imagawa
Organization Yokohama City University
Division name Pediatrics
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL 045-787-2800
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yokohama City University
Division name Pediatrics
Zip code
Address
TEL 045-787-2800
Homepage URL
Email

Sponsor
Institute Pediatrics Yokohama City Univesrity
Institute
Department

Funding Source
Organization Pediatrics Yokohama City Univesrity
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

Other administrative information
Date of disclosure of the study information
2007 Year 05 Month 01 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
Date of protocol fixation
2005 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2007 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 04 Month 18 Day
Last modified on
2007 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000819

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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