SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

Summary

Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors, 12 years of age and older, who are either on long term prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding event (BE), or who are not on prophylactic treatment who may need to control a BE.

Timeline

Start

2021-06-28

Primary completion

2026-09-30

Completion

2027-03-31

Publications

• Chrisentery-Singleton T, Acharya S, Ahuja S, Amos LE, Chitlur M, Daoud N, Eason A, Escobar M, Fedor C, Gupta S, Kuriakose P, Nasr S, Pennington S, Pruthi RK, Recht M, Robertson A, Quon DV, Wheeler AP, Reding M. Safety and real-world effectiveness of eptacog beta with emicizumab prophylaxis: an interim analysis of the ATHN 16 study. Blood Vessel Thromb Hemost. 2026 Apr 19;3(3):100169. doi: 10.1016/j.bvth.2026.100169. eCollection 2026 Aug.

Drugs

Indications