Efficacy and safety of a recombinant factor IX (Bax326) in previously treated patients with severe or moderately severe haemophilia B undergoing surgical or other invasive procedures: a prospective, open-label, uncontrolled, multicentre, phase III study-Reference-Cited by-同舟云学术

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Efficacy and safety of a recombinant factor IX (Bax326) in previously treated patients with severe or moderately severe haemophilia B undergoing surgical or other invasive procedures: a prospective, open-label, uncontrolled, multicentre, phase III study

Published:2014-04-03 Issue:5 Volume:20 Page:651-658
ISSN:1351-8216
Container-title:Haemophilia
language:en
Short-container-title:Haemophilia

Author:

Windyga J.¹,Lissitchkov T.²,Stasyshyn O.³,Mamonov V.⁴,Ghandehari H.⁵,Chapman M.⁶,Fritsch S.⁶,Wong W.-Y.⁵,Pavlova B. G.⁶,Abbuehl B. E.⁶

Affiliation:

1. Institute of Hematology and Transfusion Medicine; Warsaw Poland

2. Specialized Hematological Hospital “Joan Pavel”; Sofia Bulgaria

3. State Institution “Institute of Blood Pathology and Transfusion Medicine of the Academy of Medical Sciences of Ukraine”; Lviv Ukraine

4. Hematological Research Center; Moscow Russia

5. Baxter BioScience Global Research & Development; Westlake Village; CA USA

6. Baxter BioScience Global Clinical Research & Development; Vienna Austria

Funder

Baxter International

Publisher

Wiley

Subject

Genetics (clinical),Hematology,General Medicine

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/hae.12419/fullpdf

Reference24 articles.

1. Haemophilia B: from molecular diagnosis to gene therapy;Castaldo;Clin Chem Lab Med,2003

2. The haemophilias: from royal genes to gene therapy;Mannucci;N Engl J Med,2001

3. Clinical evaluation of recombinant factor IX;White;Semin Hematol,1998

4. Human recombinant factor IX: safety and efficacy studies in haemophilia B patients previously treated with plasma-derived factor IX concentrates;Roth;Blood,2001

5. Pharmacokinetics, efficacy and safety of BAX326, a novel recombinant factor IX: a prospective, controlled, multicentre phase I/III study in previously treated patients with severe (FIX level <1%) or moderately severe (FIX level ≤2%) haemophilia B;Windyga;Haemophilia,2014

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1. Recombinant factor IX Fc for major surgery in hemophilia B: factor IX plasma activity levels and effective hemostasis;Research and Practice in Thrombosis and Haemostasis;2023-08

2. Managing surgery in hemophilia with recombinant factor VIII Fc and factor IX Fc: Data on safety and effectiveness from phase 3 pivotal studies;Research and Practice in Thrombosis and Haemostasis;2022-07

3. International consensus recommendations on the management of people with haemophilia B;Therapeutic Advances in Hematology;2022-01

4. Single centre, real‐world experience of perioperative rFIXFc use in adult patients with haemophilia B undergoing major and minor surgery;Haemophilia;2021-10-06

5. Clotting factor concentrates for preventing bleeding and bleeding-related complications in previously treated individuals with haemophilia A or B;Cochrane Database of Systematic Reviews;2021-08-18

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