Population pharmacokinetic modeling for dose setting of nonacog beta pegol (N9-GP), a glycoPEGylated recombinant factor IX
نویسندگان
چکیده
منابع مشابه
Recombinant long-acting glycoPEGylated factor IX in hemophilia B: a multinational randomized phase 3 trial.
This multinational, randomized, single-blind trial investigated the safety and efficacy of nonacog beta pegol, a recombinant glycoPEGylated factor IX (FIX) with extended half-life, in 74 previously treated patients with hemophilia B (FIX activity ≤2 IU/dL). Patients received prophylaxis for 52 weeks, randomized to either 10 IU/kg or 40 IU/kg once weekly or to on-demand treatment of 28 weeks. No...
متن کاملPopulation Pharmacokinetic Modelling of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Patients with Haemophilia B
BACKGROUND AND OBJECTIVES Recombinant factor IX Fc fusion protein (rFIXFc) is a clotting factor developed using monomeric Fc fusion technology to prolong the circulating half-life of factor IX. The objective of this analysis was to elucidate the pharmacokinetic characteristics of rFIXFc in patients with haemophilia B and identify covariates that affect rFIXFc disposition. METHODS Population p...
متن کاملProlonged half-life and preserved enzymatic properties of factor IX selectively PEGylated on native N-glycans in the activation peptide.
Current management of hemophilia B entails multiple weekly infusions of factor IX (FIX) to prevent bleeding episodes. In an attempt to make a longer acting recombinant FIX (rFIX), we have explored a new releasable protraction concept using the native N-glycans in the activation peptide as sites for attachment of polyethylene glycol (PEG). Release of the activation peptide by physiologic activat...
متن کاملExpression of Recombinant Factor IX Using the Transient Gene Expression Technique
Background: Pilot and large-scale production of recombinant proteins requires the presence of stable clones capable of producing large quantities of recombinant proteins. Not only the process of selecting stable clones is time consuming, but also the continuous culturing of clones in large-scale production may cause loss of incoming plasmid and recombinant genes. Thus, considering the advanceme...
متن کاملThe Relationship of Secretion and Activity of Recombinant Factor IX with N-Glycosylation
Background: Human coagulation factor IX (hFIX) is a glycoprotein with two N-glycosylation sites at the activation peptide. Since the activation peptide is removed in mature hFIX, the exact role of N-glycosylation is unclear. To investigate the role of N-glycosylation in the secretion and activity of hFIX, we inhibited N-glycosylation by tunicamycin in the stable Human Embryonic Kidney (HEK)- c...
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ژورنال
عنوان ژورنال: Journal of Thrombosis and Haemostasis
سال: 2012
ISSN: 1538-7933
DOI: 10.1111/jth.12000