A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors

Summary

This is a phase IIIb, single arm, open-label, multi-center study to evaluate the safety and tolerability of emicizumab in participants with congenital hemophilia A who have documented inhibitors against Factor VIII (FVIII) at enrollment. Approximately 200 participants, aged 12 or older, will be enrolled in this study and are expected to be enrolled at approximately 85 sites globally. Participants will receive an initial weekly dose of prophylactic emicizumab subcutaneously for 4 weeks, followed by a weekly maintenance dose subcutaneously for the remainder of the 2-year treatment period.

Timeline

Start

2017-09-05

Primary completion

2020-11-19

Completion

2020-11-19

Publications

• Castaman G, Peyvandi F, Kremer Hovinga JA, Schutgens REG, Robson S, Moreno K, Jimenez-Yuste V. Surgical Experience from the STASEY Study of Emicizumab Prophylaxis in People with Hemophilia A with Factor VIII Inhibitors. TH Open. 2024 Jan 12;8(1):e42-e54. doi: 10.1055/s-0043-1777766. eCollection 2024 Jan.

Drugs

Indications