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Masahiro Takeyama, Keiji Nogami, Ryohei Kobayashi, Kenichi Ogiwara, Akira Taniguchi, Yasuaki Nakanishi, Yusuke Inagaki, Yasuhito Tanaka, Midori Shima
Continuous infusions (CI) of factor (F)VIII are preferable to the conventional bolus injections for the maintenance of consistent FVIII levels during surgery in patients with severe hemophilia A. A third generation, B domain-truncated recombinant FVIII (turoctocog alfa, Novo Nordisk, NovoEight® ), was approved for clinical use in 2014. The hemostatic efficacy and safety of bolus injections of turoctocog alfa in patients undergoing surgery have been reported, but no reports on CI therapy have been published...
January 30, 2018: International Journal of Hematology
W Pickering, M Hansen, M Kjalke, M Ezban
UNLABELLED: Essentials Chromogenic assays may be less variable than one-stage clot assays for measuring modified factor VIII. Chromogenic assays were evaluated for N8-GP potency labeling and postadministration monitoring. There was no significant difference between chromogenic assay kits for measuring N8-GP potency. Postadministration monitoring of N8-GP was comparable to turoctocog alfa for all kits tested. SUMMARY: Background Factor VIII activity ( FVIII: C) is commonly measured using one-stage activated partial thromboplastin time (aPTT)-based clot assays...
August 2016: Journal of Thrombosis and Haemostasis: JTH
P B Johansen, M Tranholm, J Haaning, T Knudsen
INTRODUCTION: The tail tip bleeding model and the tail vein transection survival model in mice are important tools for assessment of in vivo effect in haemostasis research. While the tail vein transection model exhibits the best sensitivity to pharmacological intervention it uses death or near-death as endpoint which is fully avoided in the tail tip bleeding model. AIM: The aim of this study was to develop a new tail bleeding model maintaining the sensitivity of the previous survival model but avoiding death/near-death as endpoint...
July 2016: Haemophilia: the Official Journal of the World Federation of Hemophilia
Haleh Ahmadian, Ernst B Hansen, Johan H Faber, Lars Sejergaard, Johan Karlsson, Gert Bolt, Jens J Hansen, Lars Thim
Turoctocog alfa (NovoEight) is a third-generation recombinant factor VIII (rFVIII) with a truncated B-domain that is manufactured in Chinese hamster ovary cells. No human or animal-derived materials are used in the process. The aim of this study is to describe the molecular design and purification process for turoctocog alfa. A five-step purification process is applied to turoctocog alfa: protein capture on mixed-mode resin; immunoaffinity chromatography using a unique, recombinantly produced anti-FVIII mAb; anion exchange chromatography; nanofiltration and size exclusion chromatography...
July 2016: Blood Coagulation & Fibrinolysis: An International Journal in Haemostasis and Thrombosis
A Tiede, R Klamroth, J Oldenburg
Turoctocog alfa (NovoEight®) is a new recombinant factor VIII (rFVIII) with a truncated B domain and a high degree of tyrosine sulphation, similar to plasma-derived FVIII products. The manufacturing process includes double nanofiltration with a 20-nm pore size and immunoaffinity chromatography with monoclonal F25 anti-FVIII antibodies. Treatment with turoctocog alfa can be monitored with both one-stage and chromogenic substrate assays without a product-specific laboratory standard. In total, 213 previously-treated patients with severe haemophilia A participated in the pivotal part of the clinical trial programme guardianTM...
2015: Hämostaseologie
M Ozelo, P Chowdary, A Regnault, A K Busk
Haemophilia and its treatment interfere with patients' life and may affect adherence to treatment. This study explored the impact of severe haemophilia A on patients' health status, especially in young adults (YA), using data from guardian(™) 1, a multinational, open-label, non-controlled phase 3 trial investigating safety and efficacy of turoctocog alfa (NovoEight(®) ) in previously treated patients aged 12 years and older with severe haemophilia A (FVIII ≤ 1%). Health status was assessed using the EuroQoL-5 dimensions (EQ-5D-3L), covering 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), and a visual analogue scale (VAS) measuring self-rated overall health status...
July 2015: Haemophilia: the Official Journal of the World Federation of Hemophilia
V Jiménez-Yuste, S Lejniece, R Klamroth, T Suzuki, E Santagostino, F A Karim, T Saugstrup, J Møss
BACKGROUND: Turoctocog alfa (NovoEight(®)) is a human recombinant coagulation factor VIII (rFVIII) for the treatment of patients with hemophilia A. OBJECTIVES: To evaluate the pharmacokinetics of turoctocog alfa in all age groups across clinical trials. PATIENTS/METHODS: Data from previously treated patients with severe hemophilia A (FVIII activity level of ≤ 1%) with no history of FVIII inhibitors, in a non-bleeding state, were included...
March 2015: Journal of Thrombosis and Haemostasis: JTH
E Santagostino, S R Lentz, M Misgav, B Brand, P Chowdary, A Savic, Y Kilinc, Y Amit, A Amendola, L P Solimeno, T Saugstrup, I Matytsina
Recombinant factor VIII (rFVIII) products provide a safe and efficacious replacement therapy for prevention and treatment of bleeding episodes in patients with haemophilia A. The present investigations from the multinational, open-label guardian(™) clinical trials assessed the haemostatic response of turoctocog alfa (NovoEight(®)), a rFVIII product, in patients with severe haemophilia A (FVIII ≤ 1%) undergoing surgery. All patients had a minimum of 50 exposure days to any FVIII product prior to surgery and no history of inhibitors...
January 2015: Haemophilia: the Official Journal of the World Federation of Hemophilia
Mirella Ezban, Knud Vad, Marianne Kjalke
Turoctocog alfa (NovoEight®) is a recombinant factor VIII (rFVIII) with a truncated B-domain made from the sequence coding for 10 amino acids from the N-terminus and 11 amino acids from the C-terminus of the naturally occurring B-domain. Turoctocog alfa is produced in Chinese hamster ovary (CHO) cells without addition of any human- or animal-derived materials. During secretion, some rFVIII molecules are cleaved at the C-terminal of the heavy chain (HC) at amino acid 720, and a monoclonal antibody binding C-terminal to this position is used in the purification process allowing isolation of the intact rFVIII...
November 2014: European Journal of Haematology
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