UMIN ID: UMIN000000683
Registered date:01/05/2007
Infliximab open labeled trial of efficacy and safty against intractable Kawasaki disease
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Kawasaki disease |
| Date of first enrollment | 2006/07/01 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 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. |
Outcome(s)
| Primary Outcome | Development coronary lesion at 4 weeks after treatment |
|---|---|
| Secondary Outcome | Improvement of fever and inflammatory finding at 7 days and 4 weeks after treatment |
Key inclusion & exclusion criteria
| Age minimum | 2years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | Pediatrics Yokohama City Univesrity |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Pediatrics Yokohama City Univesrity |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 045-787-2800 |
| Affiliation | Yokohama City University Pediatrics |
| scientific contact | |
| Name | Tomoyuki Imagawa |
| Address | 3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan Japan |
| Telephone | 045-787-2800 |
| Affiliation | Yokohama City University Pediatrics |