Factor VIII recovery after a single infusion of recalibrated ReFacto® in 14 severe haemophilia A patients

Haemophilia

Volumn 13, Issue 4, 2007, Pages 357-360

  Lambert, Thierry ^a   Guerois C ^b   Gay, V ^c   Stieltjes, N ^d   Bertrand, M A ^e   Derlon, A ^f   Sigaud, M ^g   Hassoun, A ^h   Negrier C ⁱ   Coatmelec, B ^j   Dreyfus, M ^a   Dubanchet, A ^k  

^a BICÊTRE HOSPITAL   (France)

^b UNIVERSITY HOSPITAL OF TOURS   (France)

^c CH Chambéry ^*  (France)

^d CHU Cochin AP HP   (France)

^e UNIVERSITY HOSPITAL OF BESANÇON   (France)

^f CAEN UNIVERSITY HOSPITAL   (France)

^g NANTES UNIVERSITY HOSPITAL   (France)

^h Hôpital S Veil   (France)

ⁱ Centre Rey Leroux   (France)

^j EDOUARD HERRIOT HOSPITAL   (France)

^k Wyeth Pharmaceuticals France   (France)

more..

Author keywords

Dosage; FVIII; Haemophilia A; Pharmaco kinetics; Recovery

Indexed keywords

BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 8 CONCENTRATE; CHROMOGENIC SUBSTRATE; RECOMBINANT BLOOD CLOTTING FACTOR 8;

ABSENCE OF SIDE EFFECTS; ADOLESCENT; ADULT; ARTICLE; BLOOD CLOTTING; CLINICAL ARTICLE; CLINICAL TRIAL; DISEASE SEVERITY; DRUG FORMULATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG POTENCY; DRUG QUALITY; HEMOPHILIA A; HUMAN; IN VIVO STUDY; MALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROTEIN FUNCTION; SCHOOL CHILD; SINGLE DRUG DOSE;

ADOLESCENT; ADULT; BLOOD COAGULATION FACTOR INHIBITORS; CHILD; DOSE-RESPONSE RELATIONSHIP, DRUG; FACTOR VIII; HEMOPHILIA A; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; REFERENCE STANDARDS; THERAPEUTIC EQUIVALENCY;

EID: 34447254711     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2007.01482.x     Document Type: Article

References (12)

1. Kessler CM, Gill JC, White GC II 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.
2. Lusher JM, Lee CA, Kessler CM et al. The safety and efficacy of B-domain deleted recombinant factor VIII concentrate in patients with severe haemophilia A. Haemophilia 2003; 9: 38-49.
3. Lusher JM, Roth DA. The safety and efficacy of B-domain deleted recombinant factor VIII concentrate in patients with severe haemophilia A: An update. Haemophilia 2005; 11: 292-3.
4. Hubbard AR, Sands D, Sandberg E et al. A multi-centre collaborative study on the potency estimation of ReFacto. Thromb Haemost 2003; 90: 1088-93.
5. European Agency for the Evaluation of Medicinal Products, EMEA public statement on ReFacto ®, 27 May 2003, CPMP/2337/03, http://www.emea.europa.eu/pdfs/human/press/pus/233703en.pdf
6. Lee M, Morfini M, Schulman S et al. The Design and Analysis of Pharmacokinetic Studies of Coagulation Factors. ISTH website. Available at: http://www.med.unc.edu/isth/, posted on website 21 March 2001.
7. Morfini M, Lee M, Messori A. The design and analysis of half-life and recovery studies for factor VIII and factor IX. Factor VIII/Factor IX Scientific and Standardization Committee of the International Society for Thrombosis and Haemostasis. Thromb Haemost 1991; 66: 384-6.
8. Rothschild C, Scharrer I, Brackmann HH et al. European data of a clinical trial with a sucrose formulated recombinant factor VIII in previously treated haemophilia A patients. Haemophilia 2002; 8 (Suppl. 2): 10-4.
9. Morfini M, Gringeri A, Cinotti S et al. Pharmacokinetic comparison of three rFVIII: Full-length rFVIII, full-length sucrose-formulated rFVIII, and B-domain deleted rFVIII. Blood 2002; 10: 710 (abstract 2798).
10. Tarantino MD, Collins PW, Hay CRM et al. Clinical evaluation of an advanced category antihaemophilic factor prepared using a plasma/ albumin-free method: Pharmacokinetics, efficacy and safety in previously treated patients with haemophilia A. Haemophilia 2004; 10: 428-37.
11. Smith KJ, Lusher JM, Cohen AM, Salzman P. Initial clinical experience with a new pasteurized monoclonal antibody purified factor VIIIC. Semin Hematol 1990; 27 (Suppl. 2): 25-9.
12. Smith MP, Giangrande P, Pollman P et al. A postmarketing surveillance study of the safety and efficacy of ReFacto (St Louis-derived active substance) in patients with haemophilia A. Haemophilia 2005; 11: 25-9.