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Methods In this phase 1 dose-escalation study, we enrolled 4 healthy volunteers and 25 participants with moderate or severe hemophilia A or B who did not have inhibitory alloantibodies. Healthy volunteers received a single subcutaneous injection of fitusiran (at a dose of 0.03 mg per kilogram of body weight) or placebo. The participants with hemophilia received three injections of fitusiran administered either once weekly (at a dose of 0.015, 0.045, or 0.075 mg per kilogram) or once monthly (at a dose of 0.225, 0.45, 0.9, or 1.8 mg per kilogram or a fixed dose of 80 mg). The study objectives were to assess the pharmacokinetic and pharmacodynamic characteristics and safety of fitusiran. Results No thromboembolic events were observed during the study.
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The most common adverse events were mild injection-site reactions. Plasma levels of fitusiran increased in a dose-dependent manner and showed no accumulation with repeated administration. The monthly regimen induced a dose-dependent mean maximum antithrombin reduction of 70 to 89% from baseline. A reduction in the antithrombin level of more than 75% from baseline resulted in median peak thrombin values at the lower end of the range observed in healthy participants. Supported by Alnylam Pharmaceuticals. Provided by the authors are available with the full text of this article at NEJM.org. This article was published on July 10, 2017, at NEJM.org.
We thank all the study participants and their family members; investigators Sarah Mangles, Catherine Bagot, and Brigitte Brand-Staufer and Alnylam employees Kate Madigan, Huy Van Nguyen, Amy Simon, Lauren Melton, Chris Lynam, Joseph Vogel, Ashley Gosnell, Prasoon Chaturvedi, Ali Seddighzadeh, Alfica Sehgal, Zakaria Khondker, and Jihong Chen for their contributions to the study; and Amy Monpara and Angela Partisano of Alnylam Pharmaceuticals for their assistance in the preparation of an earlier version of the manuscript. Source Information From the Royal London Haemophilia Centre, Barts and the London School of Medicine and Dentistry (K.J.P.), National Institute for Health Research (NIHR) Biomedical Research Centre (T.M.), Guy’s and St. Thomas’ NHS Foundation Trust, King’s College London (D.B.), St. George’s Healthcare NHS Trust Haemophilia Centre (S.A.), and Royal Free Hospital London (P.C.), London, the Haemophilia, Haemostasis and Thrombosis Centre, Hampshire Hospitals NHS Foundation Trust, Basingstoke (S.R.), Quintiles IMS, Reading (T.M.), Royal Cornwall Hospitals NHS Trust, Truro (M.D.C.), Manchester Royal Infirmary, Manchester (C.R.H.), and University Hospital Southampton NHS Foundation Trust, Southampton (R.K.) — all in the United Kingdom; University Multiprofile Hospital for Active Treatment Sveti Georgi and Medical University Plovdiv, Plovdiv (P. Georgiev), University Hospital for Hematology, Sofia (T.L.), and the Department of Hematology, University Hospital of St. Marina, Varna (L.G.-K.) — all in Bulgaria; University Hospital of Zurich, Zurich, Switzerland (I.H.); National Research Center for Hematology, Moscow (V.M.), and Research Institution of Hematology and Blood Transfusion, Kirov (M.T.) — both in Russia; Alnylam Pharmaceuticals, Cambridge (C.-H.S., P. Garg, A.V., A.A., B.S.), and Codiak Biosciences, Woburn (B.S.) — both in Massachusetts; and the University of Pittsburgh and Hemophilia Center of Western Pennsylvania, Pittsburgh (M.V.R.).