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Hematology

35+ Years Treating Hemophilia

CSL Behring has over 35 years of experience in the field of hematology. From disorders that span the coagulation cascade to the management of urgent reversal of acquired bleeding, CSL Behring continues to invest in this area and remains committed to continuing our innovations in this field.

Key Publications

Gene Therapy Research in Hemophilia

Final Analysis from the Pivotal Phase 3 HOPE-B Gene Therapy Trial: Stable Steady-State Efficacy and Safety of Etranacogene Dezaparvovec in Adults with Severe or Moderately Severe Hemophilia B
Miesbach W, Leebeek FW, Recht M, et al. EAHAD 2022
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Multiple-year Durability Data from a Phase 2b Trial of Gene Therapy with Etranacogene Dezaparvovec in Patients with Hemophilia B
Gomez E, Castaman G, Key N, et al. EAHAD 2022
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52 Week Efficacy and Safety of Etranacogene Dezaparvovec in Adults with Severe or Moderately-severe Hemophilia B: Data from the Phase 3 HOPE-B Gene Therapy Trial
Pipe SW, Leebeek FW, Recht M, et al. ISTH 2021
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Liver Safety Case Report from the Phase 3 HOPE-B Gene Therapy Trial in Adults with Hemophilia B
Schmidt M, Foster G, Coppens M, et al. ISTH 2021
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Management of Infusion Reactions: Lessons from the Phase 3 HOPE- B Gene Therapy Trial of Etranacogene Dezaparvovec in Adults with Hemophilia B
Recht M, Leebeek FW, Miesbach W, et al. ISTH 2021
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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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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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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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Fibrinogen Deficiency

Efficacy and tolerability of a pasteurized human fibrinogen concentrate in patients with congenital fibrinogen deficiency
Kreuz W, Meili E, Peter-Salonen K, et al. Transfusion and Apheresis Science 2005
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Pharmacokinetic properties of a pasteurized fibrinogen concentrate.
W. Kreuz, E. Meili, K. Peter-Salonen., et al. Transfusion and Apheresis Science 2005
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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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For U.S. Healthcare Professionals only
For U.S. Healthcare Professionals only

The purpose of this CSL Behring Medical Affairs website is to support Healthcare Professionals with scientific information. This website is also a channel for U.S. Healthcare Professionals to submit questions or connect with CSL Behring U.S. Healthcare Professionals. The information provided is for educational purposes only and is not intended to promote any products. By continuing to use this site you are acknowledging that you are a US Healthcare Professional