Efficacy, safety, and pharmacokinetics of emicizumab prophylaxis given every 4 weeks in people with haemophilia A (HAVEN 4): a multicentre, open-label, non-randomised phase 3 study.
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C. Hermans | V. Jiménez‐Yuste | S. Chebon | A. Kiialainen | N. Key | S. Pipe | A. Shapiro | M. Shima | M. Lehle | G. Levy | K. Peerlinck | K. Fukutake | C. Schmitt | M. Podolak-Dawidziak | A. Portron | Nives Selak Bienz | A. Campinha-Bacote
[1] J. Oldenburg,et al. Emicizumab Prophylaxis Provides Flexible and Effective Bleed Control in Children with Hemophilia Α with Inhibitors: Results from the HAVEN 2 Study , 2018, Blood.
[2] J. Oldenburg,et al. Bleeding events and safety outcomes in persons with haemophilia A with inhibitors: A prospective, multi‐centre, non‐interventional study , 2018, Haemophilia : the official journal of the World Federation of Hemophilia.
[3] H. Fukase,et al. Relative and Absolute Bioavailability Study of Emicizumab to Bridge Drug Products and Subcutaneous Injection Sites in Healthy Volunteers , 2018, Clinical pharmacology in drug development.
[4] J. Oldenburg,et al. Emicizumab Prophylaxis in Patients Who Have Hemophilia A without Inhibitors , 2018, The New England journal of medicine.
[5] J. Oldenburg,et al. Bleeding Events and Safety Outcomes in Pediatric Persons with Hemophilia A with Inhibitors: The First Non-Interventional Study (NIS) from a Real-World Setting , 2017 .
[6] N. Kotani,et al. A Pharmacometric Approach to Substitute for a Conventional Dose-Finding Study in Rare Diseases: Example of Phase III Dose Selection for Emicizumab in Hemophilia A , 2017, Clinical Pharmacokinetics.
[7] J. Oldenburg,et al. Emicizumab Prophylaxis in Hemophilia A with Inhibitors , 2017, The New England journal of medicine.
[8] S. Frostick,et al. Guidelines for the management of acute joint bleeds and chronic synovitis in haemophilia , 2017, Haemophilia : the official journal of the World Federation of Hemophilia.
[9] U. Scholz,et al. Co‐morbidities and bleeding in elderly patients with haemophilia—A survey of the German, Austrian and Swiss Society of Thrombosis and Haemostasis Research (GTH) , 2017, Haemophilia : the official journal of the World Federation of Hemophilia.
[10] P. Giangrande,et al. Clinical evaluation of glycoPEGylated recombinant FVIII: Efficacy and safety in severe haemophilia A , 2016, Thrombosis and Haemostasis.
[11] J. Oldenburg,et al. Efficacy and safety of BAY 81‐8973, a full‐length recombinant factor VIII: results from the LEOPOLD I trial , 2016, Haemophilia : the official journal of the World Federation of Hemophilia.
[12] E. Santagostino,et al. Efficacy and safety of rVIII-SingleChain: results of a phase 1/3 multicenter clinical trial in severe hemophilia A. , 2016, Blood.
[13] K. Yoneyama,et al. A first-in-human phase 1 study of ACE910, a novel factor VIII-mimetic bispecific antibody, in healthy subjects. , 2016, Blood.
[14] J. Oldenburg,et al. Novel, human cell line‐derived recombinant factor VIII (human‐cl rhFVIII; Nuwiq®) in adults with severe haemophilia A: efficacy and safety , 2016, Haemophilia : the official journal of the World Federation of Hemophilia.
[15] K. Wyrwich,et al. Interpreting important health‐related quality of life change using the Haem‐A‐QoL , 2015, Haemophilia : the official journal of the World Federation of Hemophilia.
[16] B. Konkle,et al. Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A. , 2015, Blood.
[17] R. Ljung,et al. The current status of prophylactic replacement therapy in children and adults with haemophilia , 2015, British journal of haematology.
[18] J. Mahlangu,et al. Prophylaxis vs. on-demand treatment with BAY 81-8973, a full-length plasma protein-free recombinant factor VIII product: results from a randomized trial (LEOPOLD II) , 2015, Journal of thrombosis and haemostasis : JTH.
[19] J. Oldenburg,et al. Prophylaxis in adult patients with severe haemophilia A. , 2014, Thrombosis research.
[20] R. Ljung,et al. Definitions in hemophilia: communication from the SSC of the ISTH , 2014, Journal of thrombosis and haemostasis : JTH.
[21] J. Dumont,et al. Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A. , 2014, Blood.
[22] M. Franchini,et al. Hemophilia A in the third millennium. , 2013, Blood reviews.
[23] L. Prihodova,et al. Haemophilia care in Europe – a survey of 35 countries , 2013, Haemophilia : the official journal of the World Federation of Hemophilia.
[24] C. Witmer,et al. Factor VIII inhibitors in hemophilia A: rationale and latest evidence , 2013, Therapeutic advances in hematology.
[25] J. Mahlangu,et al. Guidelines for the management of hemophilia , 2013, Haemophilia : the official journal of the World Federation of Hemophilia.
[26] Tsukasa Suzuki,et al. A bispecific antibody to factors IXa and X restores factor VIII hemostatic activity in a hemophilia A model , 2012, Nature Medicine.
[27] M. Skinner. WFH: Closing the global gap – achieving optimal care , 2012, Haemophilia : the official journal of the World Federation of Hemophilia.
[28] L. Valentino,et al. A randomized comparison of two prophylaxis regimens and a paired comparison of on-demand and prophylaxis treatments in hemophilia A management , 2012, Journal of thrombosis and haemostasis : JTH.
[29] T. Lambert,et al. Prophylaxis in haemophilia with inhibitors: update from international experience , 2010, Haemophilia : the official journal of the World Federation of Hemophilia.
[30] Y. Chatzizisis,et al. The syndrome of rhabdomyolysis: Pathophysiology and diagnosis. , 2007, European journal of internal medicine.
[31] E G Tuddenham,et al. The hemophilias--from royal genes to gene therapy. , 2001, The New England journal of medicine.
[32] B. Evatt,et al. Occurrence of hemophilia in the United States , 1998 .