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Study protocol for a phase III multicentre, randomised, open-label, blinded-end point trial to evaluate the efficacy and safety of immunoglobulin plus cyclosporin A in patients with severe Kawasaki disease (KAICA Trial).
Aoyagi R, Hamada H, Sato Y, Suzuki H, Onouchi Y, Ebata R, Nagashima K, Terauchi M, Terai M, Hanaoka H, Hata A; KAICA Trial Investigators. Aoyagi R, et al. BMJ Open. 2015 Dec 1;5(12):e009562. doi: 10.1136/bmjopen-2015-009562. BMJ Open. 2015. PMID: 26628527 Free PMC article. Clinical Trial.
Efficacy of primary treatment with immunoglobulin plus ciclosporin for prevention of coronary artery abnormalities in patients with Kawasaki disease predicted to be at increased risk of non-response to intravenous immunoglobulin (KAICA): a randomised controlled, open-label, blinded-endpoints, phase 3 trial.
Hamada H, Suzuki H, Onouchi Y, Ebata R, Terai M, Fuse S, Okajima Y, Kurotobi S, Hirai K, Soga T, Ishiguchi Y, Okuma Y, Takada N, Yanai M, Sato J, Nakayashiro M, Ayusawa M, Yamamoto E, Nomura Y, Hashimura Y, Ouchi K, Masuda H, Takatsuki S, Hirono K, Ariga T, Higaki T, Otsuki A, Terauchi M, Aoyagi R, Sato T, Fujii Y, Fujiwara T, Hanaoka H, Hata A; KAICA trial Investigators. Hamada H, et al. Lancet. 2019 Mar 16;393(10176):1128-1137. doi: 10.1016/S0140-6736(18)32003-8. Epub 2019 Mar 7. Lancet. 2019. PMID: 30853151 Clinical Trial.