Conditions: Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
Keywords: Infliximab REMICADE TA-650 intravenous immunoglobulin Kawasaki disease IVIG
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: no

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 description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: TA-650 intervention 2: Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Intervention descriptions: intervention 1: TA-650 at 5 mg per kg body weight on the day of TA-650 administration (day 0) is administered by intravenous infusion slowly over at least 2 hours. intervention 2: VGIH at 2 g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.

Protocol document: