Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A
Status:
Recruiting
Trial end date:
2026-02-13
Target enrollment:
Participant gender:
Summary
Primary Objective:
- To evaluate the long-term safety of BIVV001 in previously treated subjects with hemophilia
A
Secondary Objectives:
- To evaluate the efficacy of BIVV001 as a prophylaxis treatment.
- To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes.
- To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes.
- To evaluate the effect of BIVV001 prophylaxis on joint health outcomes.
- To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes.
- To evaluate the safety and tolerability of BIVV001 treatment.
- To assess the PK of BIVV001 based on the one stage activated partial thromboplastin time
(aPTT) and two-stage chromogenic FVIII activity assays (only applicable to Arm B).
- To evaluate the efficacy of BIVV001 for perioperative management