Albumin-Free Formulated Recombinant Factor VIII Preparations – How Big a Step Forward?

• References

• 1 Lusher JM, Arkin S, Abildgaard CF, Schwartz RS. Kogenate Previously Untreated Patient Study Group. Recombinant factor VIII for the treatment of previously untreated patients with hemophilia A. Safety, efficacy, and development of inhibitors. N Engl J Med 1993; 328: 453-9.
• 2 Bray GL, Gomperts ED, Courter S, Gruppo R, Gordon EM, Manco-Johnson M, Shapiro A, Scheibel E, White G, Lee M. Recombinate Study Group. A multicenter study of recombinant factor VIII (Recombinate): safety, efficacy, and inhibitor risk in previously untreated patients with hemophilia A. Blood 1994; 83: 2428-35.
• 3 Aygören-Pürsün E, Scharrer I. German Kogenate Study Group. A multicenter pharmacosurveillance study for the evaluation of the efficacy and safety of recombinant factor VIII in the treatment of patients with hemophilia A. Thromb Haemost 1997; 78: 1352-6.
• 4 White GC, Courter S, Bray GL, Lee M, Gomperts ED. Recombinate Previously Treated Patient Study Group. A multicenter study of recombinant factor VIII (Recombinate) in previously treated patients with hemophilia A. Thromb Haemost 1997; 77: 660-7.
• 5 Schulman S, Gitel S, Martinowitz U. Stability of factor VIII concentrates after reconstitution. Am J Hematol 1994; 45: 217-23.
• 6 McClelland DBL. Safety of human albumin as a constituent of biologic therapeutic products. Transfusion 1998; 38: 690-9.
• 7 Baxter T, Black D, Birks D. New variant Creutzfeldt-Jakob disease and treatment of haemophlia. Lancet 1998; 351: 600-1.
• 8 Ricketts MN, Cashman NR, Stratton EE, ElSaadany S. Is Creutzfeldt-Jakob disease transmitted in blood?. Emerg Infect Dis 1997; 3: 155-63.
• 9 Österberg T, Fatouros A, Mikaelsson M. Development of freeze-dried albumin-free formulation of recombinant factor VIII SQ. Pharm Res 1997; 14: 892-8.
• 10 Raut S, Di Giambattista M, Bevan SA, Hubbard AR, Barrowcliffe TW, Laub R. Modification of factor VIII in therapeutic concentrates after virus inactivation by solvent-detergent and pasteurisation. Thromb Haemost 1998; 80: 624-31.