Kawasaki Disease
Conditions
Brief summary
The purpose of this study is to evaluate the safety, efficacy and of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.
Detailed description
This clinical trial was designed as a multicenter, single-arm, and open-label clinical trial. Evaluate the incidence of coronary artery lesions in the 7th week of IVIG-SN administration, compared to the incidence of coronary artery lesions among untreated Kawasaki patients, to prove the superior efficacy of IVIG-SN.
Interventions
DRUGimmunoglobulin G
Intravenously administer a single dose of the product (2g/kg) for at least 12 hours
Sponsors
Green Cross Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
1. Pediatric patients aged 6 months - 5 years 2. Case definition for complete KD: Fever (≥ 38.5°C) for ≥ 5 days (but less than 10 days), 4/5 standard clinical criteria 3. Case definition for incomplete KD: Fever ≥ 5 days(but less than 10 days) and 3 clinical criteria plus coronary artery lesion on echocardiogram. 4. Subjects whose parents or legally acceptable representative (LAR) gave voluntary written consent to participate in this clinical trial
Exclusion criteria
1. Those whose blood test results show abnormalities of significance as follows : Platelet count \< 100,000/mm3, WBC count \<3,000 cells/mm3,Those whose hemogloblin, hematocrit or red blood cell count exceed 30% of the upper limit of the normal range or are 30% below the lower limit of the normal range. 2. Those who have been administered other clinical product in the last 30 days after this clinical trial commenced 3. Those who have been administered TNF alpha or steroid within 48 hours after being administered the test product 4. Those who plan to be inoculated with live vaccine during the clincial trial period 5. Those considered difficult to participate in clinical trial due to serious chronic diseases(e.g., cardiovascular diseases except controllable hypertension, diseases of the respiratory system concurrent with respiratory failure, metabolic disease, kidney dysfunction, hemoglobinopathy, etc.) 6. Those who have been administered an immunosuppressant or immune modifying drug in the last 3 months before the innoculation with the test product 7. Those who are HIV-positive or have immune dysfunctions including immunodeficiency 8. Those who have previously exhibited hypersensitivity or shock to IVIG agents 9. Patients with underlying liver disease or liver dysfunction with known etiology. 10. Patients with kidney dysfunction, whose Creatinine level is found to be over 2 times higher than the upper limit of the normal ranges in a screening test 11. Those who have -- or previously had -- a malignant tumor 12. Those who have previously been diagnosed with IgA deficiency 13. Those found unsuitable for undergoing the tests
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of coronary artery lesions | 7 weeks | Incidence of coronary artery lesions in the 7 weeks after IVIG-SN infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of coronary artery lesions | 2weeks | Incidence of coronary artery lesions in the 2nd week after IVIG-SN infusion |
| Total fever duration | baseline | Total fever duration after IVIG-SN infusion |
| variation of ESR, CRP, NT-proBNP,CK-MB | baseline | Evaluation in variation of ESR, CRP, NT-proBNP or BNP, and CK-MB |
Countries
South Korea
Outcome results
None listed