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

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Brief Title

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

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

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Incidence of coronary artery lesions

Secondary Outcome

 Incidence of coronary artery lesions

Condition

Kawasaki Disease

Intervention

immunoglobulin G

Study Arms / Comparison Groups

 Investigational product
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

45

Start Date

January 2012

Completion Date

September 2012

Primary Completion Date

September 2012

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
      

Gender

All

Ages

6 Months - 5 Years

Accepts Healthy Volunteers

No

Contacts

June Huh, MD,Ph.D, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT01524939

Organization ID

IVIG-SN_KD_P4


Responsible Party

Sponsor

Study Sponsor

Green Cross Corporation


Study Sponsor

June Huh, MD,Ph.D, Principal Investigator, Samsung Medical Center


Verification Date

January 2012