Clinical assessment of Optivate®, a high-purity concentrate of factor VIII with von Willebrand factor, in the management of patients with haemophilia A

Haemophilia

Volumn 17, Issue 3, 2011, Pages 456-462

  Dmoszynska, A ^a   Kuliczkowski, K ^b   Hellmann, A ^c   Trelinski, J ^d   Kloczko, J ^e   Baglin, T ^f   Hay, C ^g   O'Shaughnessy, D ^h   Zawilska, K ⁱ   Makris, M ^j   Shaikh Zaidi, R ^k   Gascoigne, E ^k   Dash, C ^k  

^a MEDICAL UNIVERSITY OF LUBLIN   (Poland)

^b WROCLAW MEDICAL UNIVERSITY   (Poland)

^c MEDICAL UNIVERSITY OF GDANSK   (Poland)

^d MEDICAL UNIVERSITY OF LODZ   (Poland)

^e MEDICAL UNIVERSITY OF BIALYSTOK   (Poland)

^f ADDENBROOKE S HOSPITAL   (United Kingdom)

^g MANCHESTER ROYAL INFIRMARY   (United Kingdom)

^h SOUTHAMPTON GENERAL HOSPITAL   (United Kingdom)

ⁱ POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

^j ROYAL HALLAMSHIRE HOSPITAL   (United Kingdom)

^k BIO PRODUCTS LABORATORY   (United Kingdom)

more..

Author keywords

Efficacy; Factor VIII; Haemophilia A; Plasma derived concentrates; Safety

Indexed keywords

RECOMBINANT BLOOD CLOTTING FACTOR 8;

ADULT; ARTICLE; BLOOD TRANSFUSION; CLINICAL ASSESSMENT; CLINICAL PROTOCOL; CONTROLLED STUDY; CONTUSION; DISEASE SEVERITY; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FEVER; HEADACHE; HEMOPHILIA A; HUMAN; INJECTION SITE ERYTHEMA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MUSCULOSKELETAL STIFFNESS; OPEN STUDY; OUTCOME ASSESSMENT; OUTCOME VARIABLE; PERIPHERAL EDEMA; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROPHYLAXIS; PROSPECTIVE STUDY; PRURITUS; RIGOR; SOMNOLENCE; TREATMENT DURATION; TREATMENT OUTCOME; VERTIGO; VIRUS INFECTION; VIRUS TRANSMISSION;

ADOLESCENT; ADULT; AGED; CHILD; DRUG COMBINATIONS; FACTOR VIII; HEMOPHILIA A; HEMORRHAGE; HEMOSTATICS; HUMANS; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); VON WILLEBRAND FACTOR; YOUNG ADULT;

EID: 79955159725     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2010.02446.x     Document Type: Article

References (31)

1. Rosendaal FR, Smit C, Briet E. Hemophilia treatment in historical perspective: a review of medical and social developments. Ann Hematol 1991; 62: 5-15.
2. Triemstra M, Rosendaal FR, Smit C, Van der Ploeg HM, Briet E. Mortality in patients with hemophilia. Changes in a Dutch population from 1986 to 1992 and 1973 to 1986. Ann Intern Med 1995; 123: 823-7.
3. Teitel JM. Safety of coagulation factor concentrates. Haemophilia 1998; 4: 393-401.
4. Kernoff PB, Lee CA, Karayiannis P. High risk of non-A non-B hepatitis after a first exposure to volunteer or commercial clotting factor concentrates: effects of prophylactic immune serum globulin. Br J Haematol 1985; 60: 469-79.
5. Carr R. AIDS and haemophilia. Biomed Pharmacother 1985; 39: 347-50.
6. Burnouf T. Safety aspects in the manufacturing of plasma-derived coagulation factor concentrates. Biologicals 1992; 20: 91-100.
7. Barbara JA, Tedder RS. Viral infections transmitted by blood and its products. Clin Haematol 1984; 13: 693-707.
8. Barker LF, Gerety RJ. The clinical problem of hepatitis transmission. Prog Clin Biol Res 1976; 11: 163-82.
9. Teitel JM. Viral safety of haemophilia treatment products. Ann Med 2000; 32: 485-92.
10. Rizza CR, Fletcher ML, Kernoff PB. Confirmation of viral safety of dry heated factor VIII concentrate (8Y) prepared by Bio Products Laboratory (BPL): a report on behalf of U.K. Haemophilia Centre Directors. Br J Haematol 1993; 84: 269-72.
11. Colvin BT, Rizza RC, Hill GH et al. Effect of dry-heating of coagulation factor concentrates at 80 degrees C for 72hours on transmission of non-A, non-B hepatitis. Study Group of the UK Haemophilia Centre Directors on Surveillance of Virus Transmission by Concentrates. Lancet 2010 (in press).
12. Thomas D. Clotting factor concentrates - whither purity? Thromb Haemost 1995; 74: 1604-6.
13. Yee TT, Lee CA, Pasi KJ. Life-threatening human parvovirus B19 infection in immunocompetent haemophilia. Lancet 1995; 345: 794-5.
14. Yee TT, Williams MD, Hill FG, Lee CA, Pasi KJ. Absence of inhibitors in previously untreated patients with severe haemophilia A after exposure to a single intermediate purity Factor VIII product. Thromb Haemost 1997; 78: 1027.
15. Pasi KJ, Hill FG. Safety trial of heated factor VIII concentrate (8Y). Arch Dis Child 1989; 64: 1463-7.
16. Brown SA, Dasani H, Collins PW. Long-term follow up of patients treated with intermediate FVIII concentrate BPL 8Y. Haemophilia 1998; 4: 89-93.
17. Kreil TR, Berting A, Kistner O, Kindermann J. West Nile virus and the safety of plasma derivatives: verification of high safety margins, and the validity of predictions based on model virus data. Transfusion 2003; 43: 1023-28.
18. Remington KM, Trejo SR, Bucznski G et al. Inactivation of West Nile, vaccinia virus and viral surrogates for relevant and emergent viral pathogens in plasma-derived products. Vox Sang 2004; 87: 10-8.
19. Darnell MER, Subbarao K, Feinstone SM, Taylor DR. Inactivation of the coronavirus that induces severe acute respiratory syndrome, SARS-CoV. J Virol Methods 2004; 121: 85-91.
20. ®, a high-purity concentrate of factor VIII with von Willebrand factor, in patients with severe haemophilia A. July 10 submitted for publication.
21. ®, a high purity, FVIII and VWF concentrate in VWD patients. Haemophilia 2010; 16 (Suppl. 4): 35 (08P07).
22. Rosendaal FR, Nieuwenhuis HK, Van Den Berg HM et al. A sudden increase in Factor VIII inhibitor development in multitransfused hemophilia A patients in the Netherlands. Blood 1993; 81: 2180-6.
23. Peerlinck K, Arnout J, Di Giambatista M et al. Factor VIII inhibitors in previously treated haemophilia A patients with a double virus-inactivated plasma derived factor VIII. Thromb Haemost 1997; 77: 80.
24. Rick ME, Walsh CE, Key NS. Congenital bleeding disorders. Hematology Am Soc Hematol Educ Program 2003; 559-74.
25. Laub R, Di Giambattista M, Fondu P et al. Inhibitors in German hemophilia A patients treated with a double virus inactivated factor VIII concentrates bind to the C2 domain of the FVIII light chain. Thromb Haemost 1999; 81:39-44.
26. Committee of Medicinal Products for Human use. Notes for guidance to assess efficacy and safety of human plasma derived factor VIII:C and factor IX:C products in clinical studies in haemophiliacs before and after authorisation, London, 2000 (CHMP/BPWG/198/95 rev.1).
27. Hay C, Baglin T, Collins P, Hill F, Keeling D. The diagnosis and management of Factor VIII and IX inhibitors; a guideline from the UK Haemophilia Centre Doctors' Organization (UKHCDO). Brit J Haematol 2000; 111: 78-90.
28. Hay CR, Brown S, Collins P, Keeling D, Liesner R. The diagnosis and management of factor VIII and IX inhibitors; a guideline from the UK Haemophilia Centre Doctors' Organisation. Brit J Haematol 2006; 133: 592-605.
29. Van den Berg HM, Fischer K. Prophylaxis for severe hemophilia: experience from European and the United States. Sem Thrombos Hemost 2003; 29: 49-54.
30. Windyga J, Lopaciuk P, Stefanska E et al. Haemophilia in Poland. Haemophilia 2006; 12: 52-57.
31. Committee of Medicinal Products for Human use. Core SPC for human plasma derived and recombinant coagulation factor VIII products, London, 2000. (CHMP/BPWG/1619/99).