The purpose of this study is to evaluate the safety, efficacy and of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Intravenously administer a single dose of the product (2g/kg) for at least 12 hours
Wonju christian Hospital
Wŏnju, Kang-won, South Korea
Gachon University Gil Hospital
Incheon, South Korea
Asan Medical center
Seoul, South Korea
Kyung Hee university at Gangdong
Seoul, South Korea
Incidence of coronary artery lesions
Incidence of coronary artery lesions in the 7 weeks after IVIG-SN infusion
Time frame: 7 weeks
Incidence of coronary artery lesions
Incidence of coronary artery lesions in the 2nd week after IVIG-SN infusion
Time frame: 2weeks
Total fever duration
Total fever duration after IVIG-SN infusion
Time frame: baseline
variation of ESR, CRP, NT-proBNP,CK-MB
Evaluation in variation of ESR, CRP, NT-proBNP or BNP, and CK-MB
Time frame: baseline
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Kyung Hee university medical center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul ST. Mary's Hospital
Seoul, South Korea