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

Kawasaki Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524939
• Other study ID #: IVIG-SN_KD_P4
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2012
• Last updated: September 19, 2012
• Start date: January 2012
• Est. completion date: September 2012

Study information

• Verified date: January 2012
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

Intervention

Drug:
• immunoglobulin G
Intravenously administer a single dose of the product (2g/kg) for at least 12 hours

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Hospital	Incheon
Korea, Republic of	Asan Medical center	Seoul
Korea, Republic of	Kyung Hee university at Gangdong	Seoul
Korea, Republic of	Kyung Hee university medical center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul ST. Mary's Hospital	Seoul
Korea, Republic of	Wonju christian Hospital	Wonju	Kang-won

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of coronary artery lesions	Incidence of coronary artery lesions in the 7 weeks after IVIG-SN infusion	7 weeks	No
Secondary	Incidence of coronary artery lesions	Incidence of coronary artery lesions in the 2nd week after IVIG-SN infusion	2weeks	No
Secondary	Total fever duration	Total fever duration after IVIG-SN infusion	baseline	No
Secondary	variation of ESR, CRP, NT-proBNP,CK-MB	Evaluation in variation of ESR, CRP, NT-proBNP or BNP, and CK-MB	baseline	No