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

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

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

Study Overview

• Status: Completed
• Conditions: Kawasaki Disease
• Intervention / Treatment: Drug: immunoglobulin G

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Gachon University Gil Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Kyung Hee University at Gangdong
  • Seoul, Korea, Republic of
    • Kyung Hee University Medical Center
  • Seoul, Korea, Republic of
    • Seoul St. Mary's Hospital
  • Kang-won
    • Wonju, Kang-won, Korea, Republic of, 220-701
      • Wonju Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Investigators: Principal Investigator: June Huh, MD,Ph.D, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: January 25, 2012
• First Submitted That Met QC Criteria: January 31, 2012
• First Posted (Estimate): February 2, 2012

Study Record Updates

• Last Update Posted (Estimate): September 20, 2012
• Last Update Submitted That Met QC Criteria: September 19, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Lymphatic Diseases; Vasculitis; Skin Diseases, Vascular; Mucocutaneous Lymph Node Syndrome; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; Immunoglobulin G
• Other Study ID Numbers: IVIG-SN_KD_P4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No