Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A

Study duration per participants will be approximately 60 weeks (maximum 8 weeks for screening and 52 weeks of treatment) All participants completing or remaining at the end of study will be offered participation in the planned extension trial.

A Phase 3 Open-label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Pediatric Patients <12 Years of Age With Severe Hemophilia A

Primary Objective: - To evaluate the safety of BIVV001 in previously treated pediatric 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 efficacy of BIVV001 for perioperative management To evaluate the safety and tolerability of BIVV001 treatment To assess the pharmacokinetics (PK) of BIVV001

Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A

Recruitment

Summary

Participation Requirements

Description

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