Recombinant, B-domain deleted factor VIII (r-VIII SQ): Pharmacokinetics and initial safety aspects in hemophilia A patients

Thrombosis and Haemostasis

Volumn 77, Issue 2, 1997, Pages 298-302

  Fijnvandraat, K ^a,b   Berntorp, E ^c   Ten Cate, J W ^b   Johnsson, H ^d   Peters, M ^a   Savidge, G ^e   Tengborn, L ^f   Spira, J ^g   Stahl, C ^g  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b ACADEMIC MEDICAL CENTER   (Netherlands)

^c LUND UNIVERSITY HOSPITAL   (Sweden)

^d KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^e ST THOMAS HOSPITAL   (United Kingdom)

^f SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^g PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD CLOTTING FACTOR 8 CONCENTRATE; RECOMBINANT BLOOD CLOTTING FACTOR 8;

ADOLESCENT; ADULT; ARTICLE; BIOEQUIVALENCE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG FORMULATION; DRUG HALF LIFE; DRUG SAFETY; HEMOPHILIA A; HUMAN; PRIORITY JOURNAL; PROTEIN DOMAIN; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE;

EID: 0031059825     PISSN: 03406245     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-0038-1655957     Document Type: Article

References (27)

1. Grosse-Bley A, Eis-Hubinger AM, Kaiser R, Oldenburg J, Brackmann HH, Schwarz TF, Schneweis KE. Serological and virological markers of human parvovirus B 19 infection in sera of hemophiliacs. Thromb Haemost 1994; 72: 503-7.
2. Mele A, Schinaia N, Ciavarella N, Emerson SV, Purcell RH and the Italian Collaborative Group. Transmission of hepatitis A to patients with hemophilia by factor VIII concentrates treated with organic solvent and detergent to inactivate viruses. Ann Intern Med 1994; 120: 1-7.
3. Operalski EA, Mosley JW. Pooled plasma derivates and Creutzfeldt-Jakob disease. Lancet 1995; 346: 1224.
4. Gitschier J, Wood WI, Goralka TM, Wion KL, Chen EY, Eaton DH, Vehar GA, Capon DJ, Lawn RM. Characterization of the human factor VIII gene. Nature 1984; 312: 326-30.
5. Limentani SA. Will recent innovations in therapy save perceived deficiencies in self-sufficiency policies? Blood Coagul Fibrinolysis 1994; 5: S81-4.
6. Toole JJ, Pittman DD, Orr EC, Murtha P, Wasley LC, Kaufman RJ. A large region (= 95 kDa) of human factor VIII is dispensable for in vitro procoagulant activity. Proc Natl Acad Sci USA 1986; 83: 5939-42.
7. Brinkhous KM, Sandberg H, Garris JB, Mattsson C, Palm M, Griggs T, Read MS. Purified human factor VIII procoagulant protein: Comparative hemostatic response after infusions into hemophilic and von Willebrand disease dogs. Proc Natl Acad Sci USA 1985; 82: 8752-6.
8. Sandberg A, Brandt J, Alin P, Stromberg S, Gray E, Bartfai J, Castro V. Glycosylation pattern of a B-domain-deleted recombinant factor VIII molecule (r-VIII SQ). Thromb Haemost 1995: 73: 1214.
9. Mikaelsson M, Eriksson B, Lind P, Lindner E, Ljungqvist A, Lofstrom A, Sandberg H, Wiken M. Manufacturing and characterization of a new B-domain deleted recombinant factor VIII, r-VIII SQ. Thromb Haemost 1993; 69: 1205.
10. Lind P, Larsson K, Spira J, Sydow-Backman M, Almstedt A, Gray E, Sandberg H. Novel forms of B-domain deleted recombinant factor VIII molecules. Eur J Biochem 1995; 232: 19-27.
11. Sandberg H, Almstedt A, Sebring S. A study on the function of a recombinant factor VIII protein with a deleted B-domain, r-VIII SQ. XXI International Congress of the World Federation of Hemophilia. Mexico City, Mexico, 1994, 106.
12. Morfini M, Lee M, Messori A. The design and analysis of half-life and recovery studies for factor VIII and factor IX. Thromb Haemost 1991; 66: 384-6.
13. Kasper CK, Aledort LM, Counts RB. A more uniform measurement of factor VIII inhibitors. Thromb Diath Haemorrh 1975; 34: 869-72.
14. Morfini M, Longo G, Messori A, Lee M, White G, Mannucci P and the Recombinate study group. Pharmacokinetic properties of recombinant factor VIII compared with a monoclonally purified concentrate (Hemofil M). Thromb Haemost 1992; 68: 433-5.
15. Giles AR, Tinlin S, Hoogendoorn H, Fournel MA, Ng P, Pancham N. In vivo characterization of recombinant factor VIII in a canine model of hemophilia A (Factor VIII deficiency). Blood 1988; 72: 335-9.
16. Barrowcliffe T. Potency issues with recombinant factor VIII. Ann Hematol 1994; 68: 589-91.
17. Mikaelsson M, Oswaldsson U, Nilsson IM. Potency and in vivo recovery of high purity factor VIII concentrates. Thromb Haemost 1994; 72: 160-1.
18. Oswaldsson U, Frank L, Sandberg H, Mikaelsson M. Comparison of factor VIII:C methods and reagents in the assay of factor VIII concentrates and post-injection patient plasma samples. XXI International Congress of the World Federation of Hemophilia. Mexico City, Mexico 1994; 257.
19. Schwartz RS, Abildgaard CF, Aledort LM. Human recombinant DNA-derived antihemophilic factor (factor VIII) in the treatment of haemophilia A. N Engl J Med 1990; 323: 1800-5.
20. Harrison JFM, Bloom A, Abildgaard CF for the rFactor VIII Clinical Trial Group. The pharmacokinetics of recombinant factor VIII. Semin Hematol 1991; 28: 29-35.
21. Kasper CK, Kim HC, Gomperts ED, Smith KJ, Salzman PM, Tipping D, Miller R, Montgomery RM. In vivo recovery and survival of monoclonalantibody purified factor VIII concentrates. Thromb Haemost 1991; 66: 730-3.
22. Messori A, Longo G, Matucci M, Morfini M, Rossi Ferrini PL. Clinical Pharmacokinetics of factor VIII in patients with classic hemophilia. Clin Pharmacokinet 1987; 13: 365-80.
23. Morfini M, Mannucci PM, Tenconi PM, Longo G, Mazzucconi MG, Rodeghiero F, Ciavarella N, De Rosa V, Arter A. Pharmacokinetics of monoclonally purified and recombinant factor VIII in patients with severe von Willebrand disease. Thromb Haemost 1993; 70: 270-2.
24. Messori A, Longo G, Morfini M, Cinotti S, Filimberti E, Giustarini G, Rossi Ferrini P. Multi-variate analysis of factors governing the pharmacokinetics of exogenous factor VIII in hemophiliacs. Eur J Clin Pharmacol 1988; 35: 663-8.
25. Carlsson M, Berntop E, Björkman S, Lindvall K. Pharmacokinetic dosing in prophylactic treatment of hemophilia A. Eur J Haematol 1993; 51: 247-52.
26. Fijnvandraat K, Peters M, ten Cate JW. Inter-individual variation in half-life of recombinant FVIII is associated with pre-infusion vWFAg levels. Br J Haematol 1995; 91: 474-6.
27. Weiss HJ, Sussman II, Hoyer LW. Stabilization of factor VIII in plasma by the von Willebrand factor. Studies on posttransfusion and dissociated factor Vin and in patients with von Willebrand's disease. J Clin Invest 1977; 60: 390-404.