Skip to content

Sivelestat Sodium Hydrate Treatment for Patients with Kawasaki Disease refractory to initial intravenous immunoglobulin therapy

Sivelestat Sodium Hydrate Treatment for Patients with Kawasaki Disease refractory to initial intravenous immunoglobulin therapy - Sivelestat Sodium Hydrate Treatment for severe Kawasaki Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013018
Enrollment
45
Registered
2014-02-01
Start date
2006-12-20
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

Administration of sivelestat sodium hydrate

Sponsors

Department of Pediatrics, Chiba University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: We diagnosed Kawasaki disease with the Japanese diagnostic guidelines for Kawasaki disease. Eligible participants are those who remained febrile (37.5 degree Celsius or more of an axillary temperature) 36 to 48 hours after beginning of initial IVIG therapy. Patients who become afebrile within 48 hours after beginning of initial IVIG therapy but become febrile again within day 9 of illness are also considered as refractory to initial IVIG therapy and enrolled in this study.

Exclusion criteria

Exclusion criteria: We excluded patients who become afebrile within 48 hours after beginning of initial IVIG therapy but become febrile again after day 10 of illness, those with concomitant severe medical disorders (eg, immunodeficiency, chromosomal anomalies, congenital heart diseases, metabolic diseases, nephritis, collagen diseases), those with suspected infectious disease, including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella, and influenza, those with allergy to some drugs and substances and those who have already been enrolled in other clinical trials.

Design outcomes

Primary

MeasureTime frame
The primary endpoint is incidence of coronary artery abnormalities during the study period, which we identified with two-dimensional echocardiography.

Countries

Japan

Contacts

Public ContactRyota Ebata

Chiba University Hospital Department of Pediatrics

eba-ryo@chiba-u.jp+81-43-222-7171

Outcome results

None listed

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