UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000683 |
|---|---|
| Receipt number | 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 00:22:51 |
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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
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
Sponsor or person
Institute
Pediatrics Yokohama City Univesrity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000819
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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