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

Purpose

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	Intervention	Phase
Kawasaki Disease	Drug: immunoglobulin G	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: Kawasaki disease

MedlinePlus related topics: Kawasaki Disease

Drug Information available for: Aspirin Immunoglobulin G

U.S. FDA Resources

Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:

Incidence of coronary artery lesions [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
Incidence of coronary artery lesions in the 7 weeks after IVIG-SN infusion

Secondary Outcome Measures:

Incidence of coronary artery lesions [ Time Frame: 2weeks ] [ Designated as safety issue: No ]
Incidence of coronary artery lesions in the 2nd week after IVIG-SN infusion
Total fever duration [ Time Frame: baseline ] [ Designated as safety issue: No ]
Total fever duration after IVIG-SN infusion
variation of ESR, CRP, NT-proBNP,CK-MB [ Time Frame: baseline ] [ Designated as safety issue: No ]
Evaluation in variation of ESR, CRP, NT-proBNP or BNP, and CK-MB

Enrollment:	45
Study Start Date:	January 2012
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	6 Months to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pediatric patients aged 6 months - 5 years
Case definition for complete KD: Fever (≥ 38.5°C) for ≥ 5 days (but less than 10 days), 4/5 standard clinical criteria
Case definition for incomplete KD: Fever ≥ 5 days(but less than 10 days) and 3 clinical criteria plus coronary artery lesion on echocardiogram.
Subjects whose parents or legally acceptable representative (LAR) gave voluntary written consent to participate in this clinical trial

Exclusion Criteria:

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.
Those who have been administered other clinical product in the last 30 days after this clinical trial commenced
Those who have been administered TNF alpha or steroid within 48 hours after being administered the test product
Those who plan to be inoculated with live vaccine during the clincial trial period
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.)
Those who have been administered an immunosuppressant or immune modifying drug in the last 3 months before the innoculation with the test product
Those who are HIV-positive or have immune dysfunctions including immunodeficiency
Those who have previously exhibited hypersensitivity or shock to IVIG agents
Patients with underlying liver disease or liver dysfunction with known etiology.
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
Those who have -- or previously had -- a malignant tumor
Those who have previously been diagnosed with IgA deficiency
Those found unsuitable for undergoing the tests

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524939

Locations

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
Seoul ST. Mary's Hospital
Seoul, Korea, Republic of
Kyung Hee university medical center
Seoul, Korea, Republic of
Kyung Hee university at Gangdong
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of

Sponsors and Collaborators

Green Cross Corporation

Investigators

Principal Investigator:

June Huh, MD,Ph.D

Samsung Medical Center

More Information

No publications provided

Responsible Party:	Green Cross Corporation
ClinicalTrials.gov Identifier:	NCT01524939 History of Changes
Other Study ID Numbers:	IVIG-SN_KD_P4
Study First Received:	January 25, 2012
Last Updated:	September 19, 2012
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases

Immunoglobulin G
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013