Safety and efficacy of a plasma-derived monoclonal purified factor VIII concentrate during 10 years of follow-up

Haemophilia

Volumn 13, Issue 6, 2007, Pages 697-700

  Mauser Bunschoten, E P ^a   Posthouwer, D ^a   Fischer, K ^b   Van Den Berg, H M ^a  

^a UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^b UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

Author keywords

Haemophilia A; Monoclonal purified; Plasma factor VIII

Indexed keywords

AAFACT; BLOOD CLOTTING FACTOR 8 CONCENTRATE; HEPATITIS C VIRUS ANTIBODY; HUMAN IMMUNODEFICIENCY VIRUS ANTIBODY; UNCLASSIFIED DRUG; VIRUS ANTIBODY;

ADOLESCENT; ADULT; ALLERGIC REACTION; ARTICLE; CLINICAL ASSESSMENT; CLINICAL EVALUATION; CONTINUOUS INFUSION; CONTROLLED STUDY; DRUG EFFICACY; DRUG HALF LIFE; DRUG MEGADOSE; DRUG SAFETY; FOLLOW UP; HEMOPHILIA A; HUMAN; LOW DRUG DOSE; MAJOR CLINICAL STUDY; PRIORITY JOURNAL; UNSPECIFIED SIDE EFFECT;

ADOLESCENT; ADULT; CHILD; CHILD, PRESCHOOL; COHORT STUDIES; FACTOR VIII; FEMALE; FOLLOW-UP STUDIES; HEMOPHILIA A; HUMANS; INFANT; MALE; MIDDLE AGED; ORTHOPEDIC PROCEDURES; PRODUCT SURVEILLANCE, POSTMARKETING; VIRUS DISEASES;

EID: 35548985746     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2007.01554.x     Document Type: Article

References (13)

1. Vossebeld PJ, Tissing MH, Van Den Berg HM et al. In vivo recovery and safety of human factor VIII product AAFACT in patients with haemophilia A. Haemophilia 2003; 9: 157-63.
2. Verbruggen B, Novakova I, Wessels H et al. The Nijmegen modification of the BetIesda assay for factor VIII:C inhibitors: improved specificity and reliability. Thromb Haemost 1995; 73: 247-51.
3. Van Den Berg HM, Roosendaal G, Voorberg J, Mauser-Bunschoten EP. Inhibitor development in a multitransfused patient with severe haemophilia A. Thromb Haemost 1999; 82: 151-2.
4. Mauser-Bunschoten EP, Zijl JA, Mali W et al. Successful treatment of severe bleeding in hemophilic target joints by selective angiographic embolization. Blood 2005; 105: 2654-7.
5. Goudemand J, Rothschild C, Demiguel V et al. Influence of the type of factor VIII concentrate on the incidence of factor VIII inhibitors in previously untreated patients with severe hemophilia A. Blood 2006; 107: 46-51.
6. 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. Dutch Hemophilia Study Group. Blood 1993; 81: 2180-6.
7. Peerlinck K, Arnout J, Di Giambattista M et al. Factor VIII inhibitors in previously treated haemophilia A patients with a double virus-inactivated plasma derived factor VIII concentrate. Thromb Haemost 1997; 77: 80-6.
8. Smid WM, van der MJ, Halie MR. Efficacy and safety of a monoclonal purified factor VIII concentrate: 5-year follow-up in previously treated HIV-negative haemophiliacs. Haemostasis 1995; 25: 229-36.
9. Kessler CM, Gill JC, White GC et al. B-domain deleted recombinant factor VIII preparations are bioequivalent to a monoclonal antibody purified plasma-derived factor VIII concentrate: A randomized, three-way crossover study. Haemophilia 2005; 11: 84-91.
10. Fischer K, van der Bom JG, Mauser-Bunschoten EP et al. Changes in treatment strategies for severe haemophilia over the last 3 decades: effects on clotting factor consumption and arthropathy. Haemophilia 2001; 7: 446-52.
11. Mosley JW, Nowicki MJ, Kasper CK et al. Hepatitis A virus transmission by blood products in the United States. Transfusion Safety Study Group.. Vox Sang 1994; 67(Suppl. 1): 24-8.
12. Mauser-Bunschoten EP, Zaaijer HL, van Drimmelen AA et al. High prevalence of parvovirus B19 IgG antibodies among Dutch hemophilia patients. Vox Sang 1998; 74: 225-7.
13. Cervenakova L, Brown P, Hammond DJ, Lee CA, Saenko EL. Factor VIII and transmissible spongiform encephalopathy: The case for safety. Haemophilia 2002; 8: 63-75.