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

NCT ID: NCT01524939

Last Updated: 2012-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-09-30

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.

Conditions

Kawasaki Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Investigational product

Group Type: EXPERIMENTAL

immunoglobulin G

Intervention Type: DRUG

Intravenously administer a single dose of the product (2g/kg) for at least 12 hours

Interventions

immunoglobulin G

Intravenously administer a single dose of the product (2g/kg) for at least 12 hours

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Green Cross Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

June Huh, MD,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Wonju christian Hospital

Wŏnju, Kang-won, South Korea

Gachon University Gil Hospital

Incheon, , South Korea

Asan Medical center

Seoul, , South Korea

Kyung Hee university at Gangdong

Seoul, , South Korea

Kyung Hee university medical center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul ST. Mary's Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

IVIG-SN_KD_P4

Identifier Type: -

Identifier Source: org_study_id