Direct comparison of two extended-half-life recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A

scientific article published on 24 June 2019

Direct comparison of two extended-half-life recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A is …
instance of (P31):
scholarly articleQ13442814

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P356DOI10.1007/S00277-019-03747-2
P932PMC publication ID6700041
P698PubMed publication ID31236667

P50authorMaurice J AhsmanQ56862900
P2093author name stringAlfonso Iorio
Erik Berntorp
Maria Elisa Mancuso
Andreas Tiede
Toshko Lissitchkov
Alexander Solms
Anita Shah
Sara Wiegmann
Tihomir Zhivkov
P2860cites workClotting factor concentrates given to prevent bleeding and bleeding-related complications in people with hemophilia A or BQ24234413
Achieving and maintaining an optimal trough level for prophylaxis in haemophilia: the past, the present and the futureQ26853631
Therapeutic and routine prophylactic properties of rFactor VIII Fc (efraloctocog alfa, Eloctate®) in hemophilia AQ28075081
Rational design of a fully active, long-acting PEGylated factor VIII for hemophilia A treatmentQ33535682
The impact of anti-drug antibodies on drug concentrations and clinical outcomes in rheumatoid arthritis patients treated with adalimumab, etanercept, or infliximab: Results from a multinational, real-world clinical practice, non-interventional studyQ33610284
Correlation between endogenous VWF:Ag and PK parameters and bleeding frequency in severe haemophilia A subjects during three-times-weekly prophylaxis with rFVIII-FS.Q34522059
Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophiliaQ34661163
Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia AQ36000862
Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A.Q37489013
Defining severity of hemophilia: more than factor levelsQ38136573
Considerations in individualizing prophylaxis in patients with haemophilia A.Q38203021
Target plasma factor levels for personalized treatment in haemophilia: a Delphi consensus statement.Q38739383
Population pharmacokinetic characterization of BAY 81-8973, a full-length recombinant factor VIII: lessons learned - importance of including samples with factor VIII levels below the quantitation limitQ38950839
Association of peak factor VIII levels and area under the curve with bleeding in patients with haemophilia A on every third day pharmacokinetic-guided prophylaxisQ39957037
Phase I study of BAY 94-9027, a PEGylated B-domain-deleted recombinant factor VIII with an extended half-life, in subjects with hemophilia A.Q41975229
Treatment adherence in hemophiliaQ42371331
Non-compartmental analysisQ44470140
Extended half-life pegylated, full-length recombinant factor VIII for prophylaxis in children with severe haemophilia A.Q45862229
Safety and efficacy of BAY 94-9027, a prolonged-half-life factor VIII.Q45863022
A randomized clinical trial of prophylaxis in children with hemophilia A (the ESPRIT Study).Q45866554
Outcome of pediatric patients with acute lymphoblastic leukemia/lymphoblastic lymphoma with hypersensitivity to pegaspargase treated with PEGylated Erwinia asparaginase, pegcrisantaspase: A report from the Children's Oncology GroupQ45873829
Recombinant factor VIII Fc fusion protein for the prevention and treatment of bleeding in children with severe hemophilia A.Q45875309
A survey of adherence to haemophilia therapy in six European countries: results and recommendationsQ45879477
Guidelines for the management of hemophiliaQ45880345
Break-through bleeding in relation to predicted factor VIII levels in patients receiving prophylactic treatment for severe hemophilia A.Q45882480
Population pharmacokinetics of recombinant factor VIII Fc fusion proteinQ45885620
Defining extended half-life rFVIII-A critical review of the evidence.Q52597091
BAY 94-9027, a PEGylated recombinant factor VIII, exhibits a prolonged half-life and higher area under the curve in patients with severe haemophilia A: Comprehensive pharmacokinetic assessment from clinical studiesQ59468800
Measurement of anti-drug antibodies to biologic drugsQ85898507
Individualized PK-based prophylaxis in severe haemophiliaQ88066819
Safety and efficacy of a glycoPEGylated rFVIII (turoctocog alpha pegol, N8-GP) in paediatric patients with severe haemophilia AQ88483168
Pharmacokinetic modelling and validation of the half-life extension needed to reduce the burden of infusions compared with standard factor VIIIQ88586127
Factor VIII activity of BAY 94-9027 is accurately measured with most commonly used assays: Results from an international laboratory studyQ89468400
P433issue9
P921main subjectpharmacokineticsQ323936
hemophilia AQ2092064
P304page(s)2035-2044
P577publication date2019-06-24
P1433published inAnnals of HematologyQ15766509
P1476titleDirect comparison of two extended-half-life recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia A
P478volume98

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Q99713537Direct comparison of two extended half-life PEGylated recombinant FVIII products: a randomized, crossover pharmacokinetic study in patients with severe hemophilia Acites workP2860

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