ATLAS-NEO (EFC17574): A Phase 3, Single-arm, Multicenter, Multinational, Open-Label, One-Way Crossover Study to Investigate the Efficacy and Safety of Fitursiran Prophylaxis in Male Participants aged >/= 12 Years with Severe Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX.
Study ID: STU-2023-0024
Summary
In standard of care (SOC) period, participants will receive on-demand or prophylactic treatment with clotting factor concentrates (CFCs) or bypassing agents (BPAs) for 6 months (from Day -168 to Day -1). In fitusiran treatment period, participants will receive subcutaneous fitusiran prophylaxis once every other month (Q2M) or once monthly (QM) for 36 months (from Day 1 to Day 1009). In case of bleeding events participants will receive IV CFCs or BPAs. Participants may receive Antithrombin concentrate (ATIIIC) as rescue medicine.
The purpose of this study is to measure the frequency of treated bleeding episodes with fitusiran in male adult and adolescent (≥12 years old) participants with hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX who have switched from their prior standard of care treatment.
