COAGULATION FACTOR IX
Sponsors
Sanofi-Aventis Recherche & Developpement, Takeda Development Center Americas Inc., Genzyme Corp.
Conditions
HemophiliaHemophilia A or Hemophilia BPatients on treatment with Factor Xa Inhibitor needing for an urgent intervention associated with a high risk of bleeding.
Phase 3
A Phase 3, single-arm, multicenter, multinational, open-label, one-way crossover study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged ≥ 12 years with severe hemophilia A or B with or without inhibitory antibodies to factor VIII or IX
Active, not recruitingCTIS2022-500221-33-01
Start: 2023-07-28Target: 17Updated: 2025-08-29
TAK-330-3001 - A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial with Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure
RecruitingCTIS2022-503012-16-00
Start: 2022-07-20Target: 224Updated: 2026-01-27
ATLAS-OLE: An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients with Hemophilia A or B, with or without Inhibitory Antibodies to Factor VIII or IX
CompletedCTIS2023-508884-59-00
Start: 2024-06-03End: 2025-11-17Target: 18Updated: 2025-08-21