Search Results - "Ezban, M"

Overestimation of N‐glycoPEGylated factor IX activity in a one‐stage factor IX clotting assay owing to silica‐mediated premature conversion to activated factor IX by Rosén, P., Rosén, S., Ezban, M., Persson, E.

“…Essentials Nonacog beta pegol (N9‐GP) activity is overestimated in clot method using silica‐based reagents. Mimicking contact activation phase with silica…”
Get full text

Measuring FVIII activity of glycopegylated recombinant factor VIII, N8‐GP, with commercially available one‐stage clotting and chromogenic assay kits: a two‐centre study by Hillarp, A., Bowyer, A., Ezban, M., Persson, P., Kitchen, S.

“…Introduction Factor VIII activity (FVIII:C) assays of samples containing glycoPEGylated recombinant FVIII such as turoctocog alfa pegol (N8‐GP) can be…”
Get full text

Measuring factor IX activity of nonacog beta pegol with commercially available one‐stage clotting and chromogenic assay kits: a two‐center study by Bowyer, A. E., Hillarp, A., Ezban, M., Persson, P., Kitchen, S.

“…Essentials Validated assays are required to precisely measure factor IX (FIX) activity in FIX products. N9‐GP and two other FIX products were assessed in…”
Get full text

Qualification of a select one‐stage activated partial thromboplastin time‐based clotting assay and two chromogenic assays for the post‐administration monitoring of nonacog beta pegol by Tiefenbacher, S., Bohra, R., Amiral, J., Bowyer, A., Kitchen, S., Lochu, A., Rosén, S., Ezban, M.

“…Essentials Nonacog beta pegol (N9‐GP) is an extended half‐life, recombinant human factor IX (FIX). One‐stage clotting (OSC) and chromogenic FIX activity assays…”
Get full text

Factor VIII chromogenic assays can be used for potency labeling and postadministration monitoring of N8‐GP by Pickering, W., Hansen, M., Kjalke, M., Ezban, M.

“…Essentials Chromogenic assays may be less variable than one‐stage clot assays for measuring modified factor VIII. Chromogenic assays were evaluated for N8‐GP…”
Get full text

Canine models of inherited bleeding disorders in the development of coagulation assays, novel protein replacement and gene therapies by Nichols, T. C., Hough, C., Agersø, H., Ezban, M., Lillicrap, D.

“…Summary Animal models of inherited bleeding disorders are important for understanding disease pathophysiology and are required for preclinical assessment of…”
Get full text

Human platelets express endothelial protein C receptor, which can be utilized to enhance localization of factor VIIa activity by Fager, A. M., Machlus, K. R., Ezban, M., Hoffman, M.

“…Essentials Factor VIIa binds activated platelets to promote hemostasis in hemophilia patients with inhibitors. The interactions and sites responsible for…”
Get full text

International comparative field study of N8 evaluating factor VIII assay performance by VIUFF, D., BARROWCLIFFE, TW, SAUGSTRUP, T., EZBAN, M., LILLICRAP, D.

“…Discrepancies between the one‐stage clotting assay and the chromogenic method, and also among different variations of each method, have been a significant…”
Get full text

Factor IX-deficient plasma spiked with N9-GP behaves similarly to N9-GP post-administration clinical samples in N9-GP ELISA and FIX activity assays by Sørensen, M. H., Andersen, S., Ezban, M.

“…Introduction: Evaluation of assay performance with new modified coagulation factors, such as N9‐GP, may require testing of different assays and assay…”
Get full text

Thrombin generation assay using factor XIa to measure factors VIII and IX and their glycoPEGylated derivatives is robust and sensitive by Waters, E. K., Hilden, I., Sørensen, B. B., Ezban, M., Holm, P. K.

“…Summary Background Conventional coagulation factor assays are associated with certain limitations, as they do not always reflect the clinical heterogeneity of…”
Get full text

A comparative analysis of heterogeneity in commercially available recombinant factor VIII products by Baunsgaard, D., Nielsen, A. D., Nielsen, P. F., Henriksen, A., Kristensen, A. K., Bagger, H. W., Ezban, M.

“…Introduction Advances in analytical technologies enable investigation of possible correlations between molecular structure, aggregation and subvisible particle…”
Get full text

A sensitive venous bleeding model in haemophilia A mice: effects of two recombinant FVIII products (N8 and Advate®) by PASTOFT, A. E., LYKKESFELDT, J., EZBAN, M., TRANHOLM, M., WHINNA, H. C., LAURITZEN, B.

“…Haemostatic effect of compounds for treating haemophilia can be evaluated in various bleeding models in haemophilic mice. However, the doses of factor VIII…”
Get full text

An activated factor VII variant with enhanced tissue factor‐independent activity speeds wound healing in a mouse hemophilia B model by Hoffman, M., Chang, J.‐Y., Ezban, M., Monroe, D. M.

“…Essentials Disorders of hemostasis can lead to delayed and defective wound healing. In hemophilia B (HB) mice, 7 days of Factor (F)IX or VIIa are needed to…”
Get full text

The pharmacokinetics and pharmacodynamics of single‐dose and multiple‐dose recombinant activated factor VII in patients with haemophilia A or B by Fernández‐Bello, I., Stenmo, C., Butta, N., Lind, V., Ezban, M., Jiménez‐Yuste, V.

“…Summary Monitoring recombinant activated factor VII (rFVIIa) treatment outcomes remains challenging. Thromboelastography (TEG) and the thrombin generation…”
Get full text

Chromogenic analysis of FIX activity in haemophilia B patients treated with nonacog beta pegol by Young, G., Ezban, M., Clausen, W. H. O., Negrier, C., Oldenburg, J., Shima, M.

Get full text

Recombinant human factor VIIa (rFVIIa) cleared principally by antithrombin following intravenous administration in hemophilia patients by AGERSØ, H., BROPHY, D. F., PELZER, H., MARTIN, E. J., CARR, M., HEDNER, U., EZBAN, M.

“…Objective: The objective of the present study was to evaluate the pharmacokinetics and the clearance pathways of rFVIIa after intravenous administration to…”
Get full text

rFVIIa and a new enhanced rFVIIa‐analogue, NN1731, reduce bleeding in clopidogrel‐treated and in thrombocytopenic rats by LAURITZEN, B., TRANHOLM, M., EZBAN, M.

“…Background: The pharmacological effect of rFVIIa occurs at the surface of activated platelets by enhancing thrombin generation at the site of vascular damage…”
Get full text

Faster onset of effect and greater efficacy of NN1731 compared with rFVIIa, aPCC and FVIII in tail bleeding in hemophilic mice by HOLMBERG, H. L., LAURITZEN, B., TRANHOLM, M., EZBAN, M.

“…Background: Recombinant factor VIIa (rFVIIa, Novoseven®) is currently used to control bleeding in hemophiliacs with inhibitors. A new rFVIIa variant, NN1731,…”
Get full text

Evaluation of the safety and pharmacokinetics of a fast‐acting recombinant FVIIa analogue, NN1731, in healthy male subjects by MØSS, J., SCHARLING, B., EZBAN, M., MØLLER SØRENSEN, T.

“…Background: NN1731 is a recombinant activated factor VII (rFVIIa) analog with enhanced activity. Objectives: This clinical trial aimed to assess the safety and…”
Get full text

Pharmacokinetics and pharmacodynamics of a new recombinant FVIII (N8) in haemophilia A mice by ELM, T., KARPF, D. M., ØVLISEN, K., PELZER, H., EZBAN, M., KJALKE, M., TRANHOLM, M.

“…N8 is a new recombinant factor VIII (rFVIII) compound produced and formulated without human‐ or animal‐derived protein. The aims of the present studies were to…”
Get full text