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

Haemophilia

Volumn 20, Issue 2, 2014, Pages 294-300

  Sommer, J M ^a   Moore, N ^a   Mcguffie Valentine, B ^a   Bardan, S ^a   Buyue, Y ^a   Kamphaus, G D ^a   Konkle, B A ^b   Pierce, G F ^a  

^a BIOGEN   (United States)

^b PUGET SOUND BLOOD CENTER   (United States)

Author keywords

B domain deleted; Chromogenic substrate assay; Factor VIII; Field study; One stage clotting assay

Indexed keywords

B-DOMAIN DELETED; CHROMOGENIC SUBSTRATE ASSAY; FACTOR VIII; FIELD STUDY; ONE-STAGE CLOTTING ASSAY;

BLOOD COAGULATION TESTS; FACTOR VIII; HEMOPHILIA A; HUMANS; REAGENT KITS, DIAGNOSTIC; RECOMBINANT PROTEINS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 84894260830     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/hae.12296     Document Type: Article

References (24)

1. Coppola A, Di CM, Di MM et al. Treatment of hemophilia: a review of current advances and ongoing issues. J Blood Med 2010; 1: 183-95.
2. Lusher JM, Hillman-Wiseman C, Hurst D. In vivo recovery with products of very high purity-assay discrepancies. Haemophilia 1998; 4: 641-5.
3. Viuff D, Barrowcliffe T, Saugstrup T, Ezban M, Lillicrap D. International comparative field study of N8 evaluating factor VIII assay performance. Haemophilia 2011; 17: 695-702.
4. Ingerslev J, Jankowski MA, Weston SB, Charles LA. Collaborative field study on the utility of a BDD factor VIII concentrate standard in the estimation of BDDr Factor VIII:C activity in hemophilic plasma using one-stage clotting assays. J Thromb Haemost 2004; 2: 623-8.
5. Barrowcliffe TW, Raut S, Sands D, Hubbard AR. Coagulation and chromogenic assays of factor VIII activity: general aspects, standardization, and recommendations. Semin Thromb Hemost 2002; 28: 247-56.
6. Hubbard AR, Weller LJ, Bevan SA. A survey of one-stage and chromogenic potencies in therapeutic factor VIII concentrates. Br J Haematol 2002; 117: 247-8.
7. Mikaelsson M, Oswaldsson U, Sandberg H. Influence of phospholipids on the assessment of factor VIII activity. Haemophilia 1998; 4: 646-50.
8. Morfini M, Cinotti S, Bellatreccia A, Paladino E, Gringeri A, Mannucci PM. A multicenter pharmacokinetic study of the B-domain deleted recombinant factor VIII concentrate using different assays and standards. J Thromb Haemost 2003; 1: 2283-9.
9. Pouplard C, Caron C, Aillaud MF et al. The use of the new ReFacto AF Laboratory Standard allows reliable measurement of FVIII:C levels in ReFacto AF mock plasma samples by a one-stage clotting assay. Haemophilia 2011; 17: e958-62.
10. Santoro C, Iorio A, Ferrante F et al. Performance of recalibrated ReFacto laboratory standard in the measurement of FVIII plasma concentration via the chromogenic and one-stage assays after infusion of recalibrated ReFacto (B-domain deleted recombinant factor VIII). Haemophilia 2009; 15: 779-87.
11. Kempton CL, Abshire TC, Deveras RA et al. Pharmacokinetics and safety of OBI-1, a recombinant B domain-deleted porcine factor VIII, in subjects with haemophilia A. Haemophilia 2012; 18: 798-804.
12. Barrowcliffe TW. Factor VIII and factor IX Sub-Committee. Recommendations for the assay of high-purity factor VIII concentrates. Thromb Haemost 1993; 70: 876-7.
13. Barrowcliffe TW, Hubbard AR, Kitchen S. Standards and monitoring treatment. Haemophilia 2012; 18(Suppl. 4): 61-5.
14. Cinotti S, Paladino E, Morfini M. Accuracy of FVIII: C assay by one-stage method can be improved using hemophilic plasma as diluent. J Thromb Haemost 2006; 4: 828-33.
15. Dumont JA, Liu T, Low SC et al. Prolonged activity of a recombinant factor VIII-Fc fusion protein in hemophilia A mice and dogs. Blood 2012; 119: 3024-30.
16. Ghetie V, Ward ES. Multiple roles for the major histocompatibility complex class I- related receptor FcRn. Annu Rev Immunol 2000; 18: 739-66.
17. Roopenian DC, Akilesh S. FcRn: the neonatal Fc receptor comes of age. Nat Rev Immunol 2007; 7: 715-25.
18. Powell JS, Josephson NC, Quon D et al. Safety and prolonged activity of recombinant factor VIII Fc fusion protein in hemophilia A patients. Blood 2012; 119: 3031-7.
19. Mahlangu J, Powell J, Ragni M et al. Phase 3 Clinical Study of Recombinant Fc Fusion Factor FVIII (rFVIIIFc) Demonstrated Safety, Efficacy, and Improved Pharmacokinetics (A-LONG). Haemophilia 2013; 19: PO104.
20. Peters RT, Toby G, Lu Q et al. Biochemical and functional characterization of a recombinant monomeric Factor VIII-Fc fusion protein. J Thromb Haemost 2013; 11: 132-41.
21. Dawson NJ, Kemball-Cook G, Barrowcliffe TW. Assay discrepancies with highly purified factor VIII concentrates. Haemostasis 1989; 19: 131-7.
22. Verbruggen B, Meijer P, Novakova I, Van HW. Diagnosis of factor VIII deficiency. Haemophilia 2008; 14(Suppl. 3): 76-82.
23. Christiansen ML, Balling KW, Persson E et al. Functional characteristics of N8, a new recombinant FVIII. Haemophilia 2010; 16: 878-87.
24. Advate Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation, 2012.