Kawasaki Disease Kawasaki disease, Children, Vasculitis, Coronary artery disease
Conditions
Sponsors
Hamada Hiromichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pediatric patients who meet the revised Diagnostic Guidelines for Kawasaki Disease version 6 2) Pediatric patients aged 4 months or older and younger than 15 years at the time of informed consent 3) Pediatric patients for whom diagnosis was made before Disease Day 9 (The day on which fever developed is defined as Disease Day 1) 4) Pediatric patients whose legal representative provided the consent in writing
Exclusion criteria
Exclusion criteria: 1) Pediatric patients who achieved defervescence before registration 2) Pediatric patients whose main disease condition is likely to be hemolytic streptococcal infection, EB virus infection, adenovirus infection, Yersinia infection, measles, or Stevens-Johnson syndrome, which are diseases similar to Kawasaki disease 3) Pediatric patients who started to receive treatment on or after Disease Day 9 4) Pediatric patients who are receiving tacrolimus (excluding topical preparation), pitavastatin, rosuvastatin, bosentan, aliskiren, grazoprevir, or pemafibrate 5) Pediatric patients who had experienced hypersensitivity to ciclosporin preparation, immunoglobulin preparation, or aspirin in the past 6) Pediatric patients whose condition is complicated by active bacterial infections including sepsis, purulent meningitis, peritonitis, and bacterial pneumonia 7) Pediatric patients who received administration of another study medication within 12 weeks before the start of study medication administration 8) Pediatric patients who were vaccinated with live vaccine/BCG within 4 weeks before the start of study medication administration or inactivated vaccine within 2 weeks before the start of study medication administration 9) Other pediatric patients who were judged to be ineligible for safe implementation of this study by the investigators or the sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The presence or absence of CAA through week 4 after enrollment CAA is defined as Z score >= 2.5. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy secondary endpoints 1) The presence or absence of CAA through week 4 after enrollment CAA is defined as Z score >= 3.0 2) The maximum Z score (continuous variable) within 4 weeks after registration 3) Incidence of patients with CAA at each assessment time point CAA is defined separately using two thresholds: Z score >= 2.5, Z score >= 3.0 4) Maximum Z score (continuous value) at each assessment point 5) Incidence of CAA in patients with the following factors a.-d. within 4 weeks after registration CAA is defined separately using two thresholds: Z score >= 2.5, Z score >= 3.0 6) Association between Z score (continuous variable) up to 4 weeks after registration, based on the following factors a.-d. a. Hematocrit b. Total bilirubin c. Blood cytokine/chemokine levels d. Blood myl9 levels Safety secondary endpoints Frequency of occurrence of adverse events | — |
Countries
Japan, Taiwan
Contacts
Public ContactShiori Uchiyama
Chiba University Hospital
Outcome results
None listed