Clinical Trial: Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: To Evaluate the Efficacy and Safety of TA-650 in Comparison With a Control Drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in Patients With Kawasaki Disease R
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with Kawasaki disease refractory to initial therapy with Intravenous Immunoglobulin (IVIG). The pharmacokinetics of TA-650 is also examined.
Detailed Summary:
Sponsor: Mitsubishi Tanabe Pharma Corporation
Current Primary Outcome: Defervescence rate within 48 hours after the start of the study drug administration [ Time Frame: Up to 48hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Duration of fever [ Time Frame: Up to Day56 ]
- Incidence of coronary artery lesions [ Time Frame: Day 3, Day 7, Day14, Day 21, Day56 ]
Original Secondary Outcome: Same as current
Information By: Mitsubishi Tanabe Pharma Corporation
Dates:
Date Received: May 9, 2012
Date Started: May 2012
Date Completion:
Last Updated: April 9, 2015
Last Verified: April 2015
