Summary of clinical experience with recombinant factor VIII products — Recombinate


Late in 1990, Baxter started a multicenter study using Recombinate in previously untreated patients. The goal of this study is to determine the relative risk of inhibitor formation with Recombinate, and it was prompted at least in part by early results of the Kogenate study, which reported a high number of inhibitors compared with an ongoing phase-II Recombinate study. There were clear-cut design differences between these two studies: the inhibitors in the Kogenate study were largely in previously untreated patients, whereas the Recombinate study going on at that time purposely covered only previously treated patients patients who had large numbers of exposure days and were at very low risk to develop inhibitors. Despite this difference in the studies, there was a concern that recombinant factor VIII in general might be immunogenic, and that there might be some fundamental difference between the two recombinant factor VIII products. It was in this atmosphere that Baxter undertook a study aimed at previously untreated patients (PUPs). This study has now been under way for over 2 years, and an update, looking particularly at inhibitor development will be presented. The study was designed for patients with severe or moderately severe hemophilia with factor VIII levels of 2% or less. No patients with mild hemophilia were entered into the Baxter study. Patients were excluded if they had received any prior treatment with any other blood product red cells, platelets, or any other material. Patients were enrolled, had a baseline factor VIII level performed and a baseline inhibitor level determined, and then were started on recombinant factor VIII. Factor VIII recovery and survival at 24h have

DOI: 10.1007/BF01774522

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@article{White1994SummaryOC, title={Summary of clinical experience with recombinant factor VIII products — Recombinate}, author={Gilbert C. White}, journal={Annals of Hematology}, year={1994}, volume={68}, pages={S7-S8} }