The investigation of the therapeutic efficacy of rapid intravenous immunoglobulin injection for acute phase Kawasaki disease

UMIN ID: UMIN000014665

Registered date:27/07/2014

Basic Information

• Recruitment status: Open public recruiting
• Health condition(s) or Problem(s) studied: Kawasaki disease
• Date of first enrollment: 2014/10/30
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Freeze-Dried Sulfonated Human Normal Immunoglobulin 2g/kg (maximum administration rate 0.06ml/kg/min)
Freeze-Dried Sulfonated Human Normal Immunoglobulin 2g/kg (maximum administration rate 0.03ml/kg/min)

Outcome(s)

• Primary Outcome: ･Duration of fever from the initiation of IVIG

Secondary Outcome

･WBC count and serum CRP, HDL-C and albumin levels before and after IVIG treatment
･Change of coronary artery diameter
･Clinical signs and symptoms, and laboratory blood markers before and after IVIG treatment
･Adverse event

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 15years-old
• Gender: Male and Female
• Include criteria: Kawasaki disease patients who are scheduled IVIG treatment

Exclude criteria

Patients with hypersensitivity to immunoglobulin.
Patients with cardiac or liver dysfunction.

Related Information

• Primary Sponsor: Jichi Medical University

Secondary Sponsor

Touro University California
National Institutes of Health (NIH)

• Source(s) of Monetary Support: Jichi Medical University