NCT01596335

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).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 1 Year – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin

Interventions

Type	Name	Description
DRUG	TA-650	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.
DRUG	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2012-05-11
• Last updated: 2026-01-07
• Results posted: 2018-09-26

Locations

8 sites across 1 country: Japan