The use of enhanced half-life coagulation factor concentrates in routine clinical practice: guidance from UKHCDO

Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial

(2016) E. Santagostino et al.   BLOOD

Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A

(2015) B. A. Konkle et al.   BLOOD

Role of enhanced half-life factor VIII and IX in the treatment of haemophilia

(2015) Ali J. Mahdi et al.   BRITISH JOURNAL OF HAEMATOLOGY

Potency determination of factor VIII and factor IX for new product labelling and postinfusion testing: challenges for caregivers and regulators

(2015) J. Dodt et al.   HAEMOPHILIA

Switching from current factor VIII (FVIII) to longer acting FVIII concentrates - what is the real potential benefit?

(2015) M. Carcao   HAEMOPHILIA

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

(2015) M. H. Sørensen et al.   HAEMOPHILIA

Transition considerations for extended half-life factor products

(2015) S. E. Croteau et al.   HAEMOPHILIA

Results of a phase I/II open-label, safety and efficacy trial of coagulation factor IX (recombinant), albumin fusion protein in haemophilia B patients

(2015) U. Martinowitz et al.   HAEMOPHILIA

Half-life extended factor VIII for the treatment of hemophilia A

(2015) A. Tiede   JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Recombinant factor VIII Fc fusion protein for the prevention and treatment of bleeding in children with severe hemophilia A

(2015) G. Young et al.   JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Recombinant long-acting glycoPEGylated factor IX in hemophilia B: a multinational randomized phase 3 trial

(2014) P. W. Collins et al.   BLOOD

Switching to recombinant factor IX Fc fusion protein prophylaxis results in fewer infusions, decreased factor IX consumption and lower bleeding rates

(2014) Jerry Powell et al.   BRITISH JOURNAL OF HAEMATOLOGY

Long-acting recombinant factor IX Fc fusion protein (rFIXFc) for perioperative management of subjects with haemophilia B in the phase 3 B-LONG study

(2014) Jerry S. Powell et al.   BRITISH JOURNAL OF HAEMATOLOGY

Evaluation of the activated partial thromboplastin time assay for clinical monitoring of PEGylated recombinant factor VIII (BAY 94-9027) for haemophilia A

(2014) J-M. Gu et al.   HAEMOPHILIA

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

(2014) T. E. Coyle et al.   JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Comparative field study: impact of laboratory assay variability on the assessment of recombinant factor IX Fc fusion protein (rFIXFc) activity

(2014) Yang Buyue et al.   THROMBOSIS AND HAEMOSTASIS

A novel B-domain O-glycoPEGylated FVIII (N8-GP) demonstrates full efficacy and prolonged effect in hemophilic mice models

(2013) H. R. Stennicke et al.   BLOOD

Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A

(2013) J. Mahlangu et al.   BLOOD

Fc-fusion proteins and FcRn: structural insights for longer-lasting and more effective therapeutics

(2013) Timo Rath et al.   CRITICAL REVIEWS IN BIOTECHNOLOGY

Comparative field study evaluating the activity of recombinant factor VIII Fc fusion protein in plasma samples at clinical haemostasis laboratories

(2013) J. M. Sommer et al.   HAEMOPHILIA

Recommendations on the potency labelling of factor VIII and factor IX concentrates

(2013) A. R. Hubbard et al.   JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Enhancing the pharmacokinetic properties of recombinant factor VIII: first-in-human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A

(2013) A. Tiede et al.   JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Phase 3 Study of Recombinant Factor IX Fc Fusion Protein in Hemophilia B

(2013) Jerry S. Powell et al.   NEW ENGLAND JOURNAL OF MEDICINE

Extending the pharmacokinetic half-life of coagulation factors by fusion to recombinant albumin

(2013) Steven W. Pipe et al.   THROMBOSIS AND HAEMOSTASIS

The hope and reality of long-acting hemophilia products

(2012) Steven W. Pipe   AMERICAN JOURNAL OF HEMATOLOGY

Safety and prolonged activity of recombinant factor VIII Fc fusion protein in hemophilia A patients

(2012) J. S. Powell et al.   BLOOD

Safety and pharmacokinetics of a novel recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in hemophilia B patients

(2012) E. Santagostino et al.   BLOOD

Diagnosis and treatment of factor VIII and IX inhibitors in congenital haemophilia: (4th edition)

(2012) Peter W. Collins et al.   BRITISH JOURNAL OF HAEMATOLOGY

Measurement of factor VIII pharmacokinetics in routine clinical practice

(2012) S. BJÖRKMAN et al.   JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Biochemical and functional characterization of a recombinant monomeric factor VIII-Fc fusion protein

(2012) R. T. PETERS et al.   JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Prolonged half-life and preserved enzymatic properties of factor IX selectively PEGylated on native N-glycans in the activation peptide

(2011) H. Ostergaard et al.   BLOOD

Recombinant factor IX-Fc fusion protein (rFIXFc) demonstrates safety and prolonged activity in a phase 1/2a study in hemophilia B patients

(2011) A. D. Shapiro et al.   BLOOD

Enhanced pharmacokinetic properties of a glycoPEGylated recombinant factor IX: a first human dose trial in patients with hemophilia B

(2011) C. Negrier et al.   BLOOD

Incidence of factor VIII inhibitors throughout life in severe hemophilia A in the United Kingdom

(2011) C. R. M. Hay et al.   BLOOD

Prolonged activity of factor IX as a monomeric Fc fusion protein

(2010) R. T. Peters et al.   BLOOD

Rational design of a fully active, long-acting PEGylated factor VIII for hemophilia A treatment

(2010) B. Mei et al.   BLOOD

A United Kingdom Haemophilia Centre Doctors’ Organization guideline approved by the British Committee for Standards in Haematology: guideline on the use of prophylactic factor VIII concentrate in children and adults with severe haemophilia A

(2010) Michael Richards et al.   BRITISH JOURNAL OF HAEMATOLOGY

Implications of coagulation factor VIII and IX pharmacokinetics in the prophylactic treatment of haemophilia

(2010) P. W. COLLINS et al.   HAEMOPHILIA

Break-through bleeding in relation to predicted factor VIII levels in patients receiving prophylactic treatment for severe hemophilia A

(2008) P. W. COLLINS et al.   JOURNAL OF THROMBOSIS AND HAEMOSTASIS