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

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.

Timeline

Start

2012-05

Primary completion

2014-10

Completion

2014-10

Publications

• Results Mori M, Hara T, Kikuchi M, Shimizu H, Miyamoto T, Iwashima S, Oonishi T, Hashimoto K, Kobayashi N, Waki K, Suzuki Y, Otsubo Y, Yamada H, Ishikawa C, Kato T, Fuse S. Infliximab versus intravenous immunoglobulin for refractory Kawasaki disease: a phase 3, randomized, open-label, active-controlled, parallel-group, multicenter trial. Sci Rep. 2018 Jan 31;8(1):1994. doi: 10.1038/s41598-017-18387-7.

Drugs

Indications