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Original Research

Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A

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Pages 273-283 | Published online: 08 Apr 2009

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Edward P. Armstrong, Daniel C. Malone, Sangeeta Krishnan & Maj Jacob Wessler. (2015) Adherence to clotting factors among persons with hemophilia A or B. Hematology 20:3, pages 148-153.
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Leonard A Valentino, Yousef Ismael & Michele Grygotis. (2010) Novel drugs to treat hemophilia. Expert Opinion on Emerging Drugs 15:4, pages 597-613.
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Santiago Bonanad, María García‐Dasí, José A. Aznar, María Eva Mingot‐Castellano, Victor Jiménez‐Yuste, MªVictoria Calle, Antonio Palma, María Fernanda López‐Fernández, Pascual Marco, María José Paloma, Nuria Fernández‐Mosteirin, Bernat Galmés, Martín Sanabria & MªPilar Álvarez. (2020) Adherence to prophylaxis in adult patients with severe haemophilia A. Haemophilia 26:5, pages 800-808.
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Jayashree Motwani, Benoit Guillet, Jan Blatny, Freimut H. Schilling, Bénédicte Wibaut, Jimena Goldstine, Andras Nagy, Jennifer Doralt, Werner Engl, Srilatha Tangada & Gerald Spotts. (2020) Postauthorization safety surveillance study of antihaemophilic factor (recombinant) reconstituted in 2 mL sterile water for injection in children with haemophilia A. Haemophilia 26:3, pages 478-486.
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Mario Schiavoni, Mariasanta Napolitano, Gaetano Giuffrida, Antonella Coluccia, Sergio Siragusa, Valeria Calafiore, Giuseppe Lassandro & Paola Giordano. (2019) Status of Recombinant Factor VIII Concentrate Treatment for Hemophilia A in Italy: Characteristics and Clinical Benefits. Frontiers in Medicine 6.
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A. D. Shapiro, J. N. Mahlangu, D. Perry, J. Pasi, D. V. Quon, P. Chowdary, E. Tsao, S. Li, A. Innes, G. F. Pierce & G. A. Allen. (2017) Treatment of bleeding episodes with recombinant factor VIII Fc fusion protein in A-LONG study subjects with severe haemophilia A. Haemophilia 23:3, pages 392-399.
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A. Iorio, A.M. Barbara, F. Bernardi, D. Lillicrap, M. Makris, F. Peyvandi & F. Rosendaal. (2016) Recommendations for authors of manuscripts reporting inhibitor cases developed in previously treated patients with hemophilia: communication from the SSC of the ISTH. Journal of Thrombosis and Haemostasis 14:8, pages 1668-1672.
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B. Brand, R. Gruppo, T. T. Wynn, L. Griskevicius, M. F. Lopez Fernandez, M. Chapman, T. Dvorak, B. G. Pavlova & B. E. Abbuehl. (2016) Efficacy and safety of pegylated full‐length recombinant factor VIII with extended half‐life for perioperative haemostasis in haemophilia A patients . Haemophilia 22:4.
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L. H. Schrijvers, M. J. Schuurmans & K. Fischer. (2016) Promoting self‐management and adherence during prophylaxis: evidence‐based recommendations for haemophilia professionals. Haemophilia 22:4, pages 499-506.
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Tamara Pérez-Robles, José A. Romero-Garrido, E. Carlos Rodriguez-Merchan & Alicia Herrero-Ambrosio. (2016) Objective quantification of adherence to prophylaxis in haemophilia patients aged 12 to 25years and its potential association with bleeding episodes. Thrombosis Research 143, pages 22-27.
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A. D. Shapiro, C. Schoenig‐Diesing, L. Silvati‐Fidell, W. Y. Wong & V. Romanov. (2015) Integrated analysis of safety data from 12 clinical interventional studies of plasma‐ and albumin‐free recombinant factor VIII (r AHF ‐ PFM ) in haemophilia A . Haemophilia 21:6, pages 791-798.
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Barbara A. KonkleOleksandra StasyshynPratima ChowdaryDavid H. BevanTim MantMidori ShimaWerner Engl, Jacqueline Dyck-Jones, Monika Fuerlinger, Lisa Patrone, Bruce Ewenstein & Brigitt Abbuehl. (2015) Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A. Blood 126:9, pages 1078-1085.
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M. García-Dasí, J. A. Aznar, V. Jiménez-Yuste, C. Altisent, S. Bonanad, E. Mingot, F. Lucía, F. Giménez, M. Fernanda López, P. Marco, R. Pérez, M. Á. Fernández, M. J. Paloma, B. Galmes, S. Herrero & J. A. García-Talavera. (2015) Adherence to prophylaxis and quality of life in children and adolescents with severe haemophilia A. Haemophilia 21:4, pages 458-464.
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Xunwei Duan, Mingqing Tang, Junping Zhang, Hao Yu & Ruian Xu. (2014) Promising coagulation factor VIII bypassing strategies for patients with haemophilia A. Blood Coagulation & Fibrinolysis 25:6, pages 539-552.
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S. V. Antunes, S. Tangada, O. Stasyshyn, V. Mamonov, J. Phillips, N. Guzman‐Becerra, A. Grigorian, B. Ewenstein & W.‐Y. Wong. (2013) Randomized comparison of prophylaxis and on‐demand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors . Haemophilia 20:1, pages 65-72.
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S. Ho, D. Gue, K. McIntosh, M. Bucevska, M. Yang & S. Jackson. (2013) An objective method for assessing adherence to prophylaxis in adults with severe haemophilia. Haemophilia 20:1, pages 39-43.
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Matthew P. Kosloski, Dipak S. Pisal, Donald E. Mager & Sathy V. Balu-Iyer. (2013) Allometry of Factor VIII and Informed Scaling of Next-Generation Therapeutic Proteins. Journal of Pharmaceutical Sciences 102:7, pages 2380-2394.
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Hartmut Pollmann, Robert Klamroth, Natascha Vidovic, Alexander Y. Kriukov, Joshua Epstein, Ingo Abraham, Gerald Spotts & Johannes Oldenburg. (2013) Prophylaxis and quality of life in patients with hemophilia A during routine treatment with ADVATE [antihemophilic factor (recombinant), plasma/albumin-free method] in Germany: a subgroup analysis of the ADVATE PASS post-approval, non-interventional study. Annals of Hematology 92:5, pages 689-698.
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Gillian M. Keating & Sohita Dhillon. (2012) Octocog Alfa (Advate®): A Guide to Its Use in Hemophilia A. BioDrugs 26:4, pages 269-273.
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Sohita Dhillon. (2012) Octocog Alfa, Antihaemophilic Factor (Recombinant), Plasma/Albumin Free Method (Advate®). Drugs 72:7, pages 987-1007.
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M. FRANCHINI, M. MAKRIS, E. SANTAGOSTINO, A. COPPOLA & P. M. MANNUCCI. (2012) Non‐thrombotic‐, non‐inhibitor‐associated adverse reactions to coagulation factor concentrates for treatment of patients with hemophilia and von Willebrand’s disease: a systematic review of prospective studies. Haemophilia 18:3.
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G. Auerswald, A. Thompson, M. Recht, D. Brown, R. Liesner, N. Guzman-Becerra, J. Dyck-Jones, B. Ewenstein & B. Abbuehl. (2012) Experience of Advate rAHF-PFM in previously untreated patients and minimally treated patients with haemophilia A. Thrombosis and Haemostasis 107:6, pages 1072-1082.
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L.A. VALENTINO, V. MAMONOV, A. HELLMANN, D.V. QUON, A. CHYBICKA, P. SCHROTH, L. PATRONE & W.‐Y. WONG. (2012) A randomized comparison of two prophylaxis regimens and a paired comparison of on‐demand and prophylaxis treatments in hemophilia A management. Journal of Thrombosis and Haemostasis 10:3, pages 359-367.
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L.M. ALEDORT, R.J. NAVICKIS & M.M. WILKES. (2011) Best evidence on B‐domain deletion and the immunogenicity of recombinant factor VIII. Journal of Thrombosis and Haemostasis 9:11, pages 2325-2327.
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L.M. ALEDORT, R.J. NAVICKIS & M.M. WILKES. (2011) Can B‐domain deletion alter the immunogenicity of recombinant factor VIII? A meta‐analysis of prospective clinical studies. Journal of Thrombosis and Haemostasis 9:11, pages 2180-2192.
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J. OLDENBURG, J. GOUDEMAND, L. VALENTINO, M. RICHARDS, H. LUU, A. KRIUKOV, H. GAJEK, G. SPOTTS & B. EWENSTEIN. (2010) Postauthorization safety surveillance of ADVATE [antihaemophilic factor (recombinant), plasma/albumin‐free method] demonstrates efficacy, safety and low‐risk for immunogenicity in routine clinical practice. Haemophilia 16:6, pages 866-877.
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