Study of Combined Therapy of Aspirin and IVIG-SN in Kawasaki Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter, Single-arm, Phase IV Study to Evaluate the Efficacy, Safety of Combined Therapy of Aspirin and High Dose IVIG-SN in Pediatric Patients With Kawasaki Disease

Conditions
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Kawasaki Disease

Intervention / Treatment
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* Drug: immunoglobulin G


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients aged 6 months - 5 years Case definition for complete KD: Fever (≥ 38.5°C) for ≥ 5 days (but less than 10 days), 4/5 standard clinical criteria Case definition for incomplete KD: Fever ≥ 5 days(but less than 10 days) and 3 clinical criteria plus coronary artery lesion on echocardiogram. Subjects whose parents or legally acceptable representative (LAR) gave voluntary written consent to participate in this clinical trial Exclusion Criteria: 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. Those who have been administered other clinical product in the last 30 days after this clinical trial commenced Those who have been administered TNF alpha or steroid within 48 hours after being administered the test product Those who plan to be inoculated with live vaccine during the clincial trial period 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.) Those who have been administered an immunosuppressant or immune modifying drug in the last 3 months before the innoculation with the test product Those who are HIV-positive or have immune dysfunctions including immunodeficiency Those who have previously exhibited hypersensitivity or shock to IVIG agents Patients with underlying liver disease or liver dysfunction with known etiology. 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 Those who have -- or previously had -- a malignant tumor Those who have previously been diagnosed with IgA deficiency Those found unsuitable for undergoing the tests

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational product<br> | Drug: immunoglobulin G<br>* Intravenously administer a single dose of the product (2g/kg) for at least 12 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of coronary artery lesions | Incidence of coronary artery lesions in the 7 weeks after IVIG-SN infusion | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of coronary artery lesions | Incidence of coronary artery lesions in the 2nd week after IVIG-SN infusion | 2weeks | 
| Total fever duration | Total fever duration after IVIG-SN infusion | baseline | 
| variation of ESR, CRP, NT-proBNP,CK-MB | Evaluation in variation of ESR, CRP, NT-proBNP or BNP, and CK-MB | baseline |