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Thromb Haemost 1997; 77(04): 660-667
DOI: 10.1055/s-0038-1656030
Clinical Studies
Schattauer GmbH Stuttgart

A Multicenter Study of Recombinant Factor VIII (RecombinateTM) in Previously Treated Patients with Hemophilia A

G C White II
The Center of Thrombosis and Hemostasis, Departments of Medicine and Pharmacology, University of North Carolina School of Medicine Chapel Hill, NC and the Dept, of Medical and Clinical Affairs, Baxter/Hyland Division, Glendale, CA, USA
,
S Courter
,
G L Bray
The Center of Thrombosis and Hemostasis, Departments of Medicine and Pharmacology, University of North Carolina School of Medicine Chapel Hill, NC and the Dept, of Medical and Clinical Affairs, Baxter/Hyland Division, Glendale, CA, USA
,
M Lee
The Center of Thrombosis and Hemostasis, Departments of Medicine and Pharmacology, University of North Carolina School of Medicine Chapel Hill, NC and the Dept, of Medical and Clinical Affairs, Baxter/Hyland Division, Glendale, CA, USA
,
The Recombinate Previously Treated Patient Study Group,
E D Gomperts
The Center of Thrombosis and Hemostasis, Departments of Medicine and Pharmacology, University of North Carolina School of Medicine Chapel Hill, NC and the Dept, of Medical and Clinical Affairs, Baxter/Hyland Division, Glendale, CA, USA
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Publikationsverlauf

Received 20. August 1996

Accepted after revision 29. November 1996

Publikationsdatum:
11. Juli 2018 (online)

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Summary

A prospective, open-label multicenter investigation has been conducted to compare pharmacokinetic parameters of recombinant DNA-derived FVIII (rFVIII) and plasma-derived FVIII concentrate (pdFVIII) and to assess safety and efficacy of long-term home-treat- ment with rFVIII for subjects with hemophilia A. Following comparative in vivo pharmacokinetic studies, 69 patients with severe (n = 67) or moderate (n = 2) hemophilia A commenced a program of home treatment using rFVIII exclusively for prophylaxis and treatment of all bleeding episodes for a period of 1.0 to 5.7 years (median 3.7 years). The mean in vivo half-lives of rFVIII and pdFVIII were both 14.7 h. In vivo incremental recoveries at baseline were 2.40%/IU/kg and 2.47%/IU/kg, respectively (p = 0.59). The response to home treatment with rFVIII was categorized as good or excellent in 3,195 (91.2%) of 3,481 evaluated bleeding episodes. Thirteen patients received rFVIII for prophylaxis for twenty-four surgical procedures. In all cases, hemostasis was excellent. Adverse reactions were observed in only 13 of 13,591 (0.096%) infusions of rFVIII; none was serious. No patient developed an inhibitor to r FVIII.

* See Appendix for the complete list of coinvestigators in the Study Group