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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01524939
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : September 20, 2012
Information provided by (Responsible Party):
Green Cross Corporation

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.

Condition or disease Intervention/treatment Phase
Kawasaki Disease Drug: immunoglobulin G Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kawasaki Disease

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

Primary Outcome Measures :
  1. Incidence of coronary artery lesions [ Time Frame: 7 weeks ]
    Incidence of coronary artery lesions in the 7 weeks after IVIG-SN infusion

Secondary Outcome Measures :
  1. Incidence of coronary artery lesions [ Time Frame: 2weeks ]
    Incidence of coronary artery lesions in the 2nd week after IVIG-SN infusion

  2. Total fever duration [ Time Frame: baseline ]
    Total fever duration after IVIG-SN infusion

  3. variation of ESR, CRP, NT-proBNP,CK-MB [ Time Frame: baseline ]
    Evaluation in variation of ESR, CRP, NT-proBNP or BNP, and CK-MB

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01524939

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Korea, Republic of
Wonju christian Hospital
Wonju, Kang-won, Korea, Republic of, 220-701
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
Sponsors and Collaborators
Green Cross Corporation
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Principal Investigator: June Huh, MD,Ph.D Samsung Medical Center

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Responsible Party: Green Cross Corporation Identifier: NCT01524939     History of Changes
Other Study ID Numbers: IVIG-SN_KD_P4
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: September 20, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Mucocutaneous Lymph Node Syndrome
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Immunoglobulin G
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Immunologic Factors