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Therapeutic Areas and Products

Hematology

Key Publications

Hemophilia B

Long-acting recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in children. Results of a phase 3 trial
G. Kenet, Chambost H.. J. Thrombosis and Hemostasis, 2016
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Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial
E. Santagostino, U. Martinowitz, et al. Blood, April 2016
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Efficacy and safety of long-acting recombinant fusion protein linking factor IX with albumin in haemophilia B patients undergoing surgery
E. Negrier et al. Haemophilia 2016
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Hemophilia A

Efficacy and safety of rVIII-SingleChain: results of a phase 1/3 multicenter clinical trial in severe hemophilia A
Mahlangu, J. Blood, 2016
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Safety, efficacy and pharmacokinetics of rVIII-SingleChain in children with severe hemophilia A: results of a multicenter clinical trial
Stasyshn, O., J. Thrombosis and Hemostasis, 2017
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Von Willebrand Disease

Pharmacokinetics, efficacy and safety of Humate-P® in von Willebrand disease
Dobrkovska, A et al, Haemophilia 1998
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von Willebrand factor/factor VIII concentrate (Humate-P) for management of elective surgery in adults and children with von Willebrand disease
Gill JC, et all. Haemophilia 2011
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von Willebrand factor/factor VIII concentrate (Haemate P) dosing based on pharmacokinetics: a prospective multicenter trial in elective surgery
Lethagen, S. et al J Thromb Haemost. 2007
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Factor XIII Deficiency

Pharmacokinetics and safety of plasma-derived factor XIII concentrate (human) in patients with congenital factor XIII deficiency
Nugent, D.j et al , Haemophilia 2015
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Efficacy and safety of prophylactic treatment with plasma-derived factor XIII concentrate (human) in patients with congenital factor XIII deficiency
Ashley, C. Et al, Haemophilia 2015
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Acquired Bleeding

Kcentra was approved by the United States (US) food and Drug Administration (FDA) on April 29, 2013.  Kcentra, under the trade name Beriplex or Confidex, has been approved in other countries since 1996. The specific drug product name that was used in the cited publications is referenced below:

BERIPLEX P/N reverses severe warfarin-induced over anticoagulation immediately and completely in patients presenting with major bleeding
Evans G, et al., Br J Haematol 2001
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Rapid reversal of oral anticoagulation with warfarin by a prothrombin complex concentrate (BERIPLEX): efficacy and safety in 42 patients
Preston F, et al., Br J Haematol 2002
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Efficacy and safety of a prothrombin complex concentrate with two virus-inactivation steps in patients with severe liver damage
Lorenz R, et al., Eur J Gastroenterol Hepatol 2003
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Pharmacokinetics of BERIPLEX P/N prothrombin complex concentrate in healthy volunteers
Ostermann H, et al., Thromb Haemost 2007
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Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial
Pabinger I, et al., Thromb Haemost 2008
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Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate. A prospective clinical trial of emergency anticoagulation reversal
Pabinger I, et al., Ann Hematol 2010
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Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: A randomized, plasma-controlled, phase IIIb study
Sarode R, et al., Circulation 2013
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Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomized trial
Goldstein JN, et al., Lancet 2015
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Increased risk of volume overload with plasma compared with four-factor prothrombin complex concentrate for urgent vitamin K antagonist reversal
Refaai, MA, et al., Transfusion 2015
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Thromboembolic Events After Vitamin K Antagonist Reversal With 4-Factor Prothrombin Complex Concentrate: Exploratory Analyses of Two Randomized, Plasma-Controlled Studies
Milling TJ Jr, et al., Ann Emerg Med 2016
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