Safety and Efficacy Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients

Summary

A study to assess the safety and efficacy of eculizumab in Japanese patients with hemolytic PNH.

Timeline

Start

2007-11

Primary completion

2008-06

Completion

2008-06

Outcome

Met primary endpoint

paper This trial achieved its primary endpoint of reducing intravascular hemolysis with high statistical significance. PMID 21222185 ↗

Publications

• Results Kanakura Y, Ohyashiki K, Shichishima T, Okamoto S, Ando K, Ninomiya H, Kawaguchi T, Nakao S, Nakakuma H, Nishimura J, Kinoshita T, Bedrosian CL, Valentine ME, Khursigara G, Ozawa K, Omine M. Safety and efficacy of the terminal complement inhibitor eculizumab in Japanese patients with paroxysmal nocturnal hemoglobinuria: the AEGIS clinical trial. Int J Hematol. 2011 Jan;93(1):36-46. doi: 10.1007/s12185-010-0748-9. Epub 2011 Jan 12.

Drugs

Indications