Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease

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 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.

Inclusion Criteria:

• Patients diagnosed with Kawasaki disease (incipient cases only) with 5 or more of the 6 major symptoms of Kawasaki disease.
• Patients refractory to initial IVIG therapy (a single administration at 2 g per kg body weight).
• Patients with a fever of 37.5ºC or higher axillary temperature at the time of enrollment.
• Patients to whom the study drug can be administered by day 8 of disease.

Exclusion Criteria:

• Patients who have received vaccination with Bacille Calmette-Guérin (BCG) vaccine within 6 months before the enrollment.
• Patients with a complication, or a history within 6 months before the enrollment of, serious infections requiring hospitalization.
• Patients with a complication, or a history within 6 months before the enrollment of, opportunistic infections.
• Patients complicated with active tuberculosis, active hepatitis B or C, or patients confirmed to be hepatitis B virus carriers or a history of hepatitis B.
• Patients confirmed to have HIV infection, or patients with a family history of HIV infection.
• Patients who have a history of receiving treatment with infliximab or other biological products.
• Patients who had participated in another clinical study and had received a study drug within 12 weeks before giving consent.