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

Green Cross Corporation

Status and phase: Completed; Phase 4

Conditions: Kawasaki Disease

Treatments: Drug: immunoglobulin G

Study type: Interventional

Funder types: Industry

Identifiers

NCT01524939

IVIG-SN_KD_P4

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, efficacy and of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Investigational product

Experimental group

Treatment:

Drug: immunoglobulin G