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Infliximab open labeled trial of efficacy and safty against intractable Kawasaki disease

Infliximab open labeled trial of efficacy and safty against intractable Kawasaki disease - Infliximab open labeled trial against intractable Kawasaki disease

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000683
Enrollment
20
Registered
2007-05-01
Start date
2006-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kawasaki disease

Interventions

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 t

Sponsors

Pediatrics Yokohama City Univesrity
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Development coronary lesion at 4 weeks after treatment

Secondary

MeasureTime frame
Improvement of fever and inflammatory finding at 7 days and 4 weeks after treatment

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026