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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Green Cross Corporation
• Treatments: Antibodies; Aspirin; Immunoglobulin G; Immunoglobulins; Immunoglobulins, Intravenous

Criteria

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