BDDrFVIII (Moroctocog alfa [AF-CC]) for surgical haemostasis in patients with haemophilia A: results of a pivotal study
Moroctocog alfa (AF‐CC) (Xyntha™, BDDrFVIII) is manufactured by a process designed to enhance the theoretical viral safety profile relative to ReFacto®, its predecessor, and to provide alignment with clinical monitoring by the one‐stage clotting assay. To evaluate the efficacy and safety of B‐domain...
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Published in | Haemophilia : the official journal of the World Federation of Hemophilia Vol. 16; no. 5; pp. 731 - 739 |
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Main Authors | , , , , , , |
Format | Journal Article |
Language | English |
Published |
Oxford, UK
Blackwell Publishing Ltd
01.09.2010
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Subjects | |
Online Access | Get full text |
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Summary: | Moroctocog alfa (AF‐CC) (Xyntha™, BDDrFVIII) is manufactured by a process designed to enhance the theoretical viral safety profile relative to ReFacto®, its predecessor, and to provide alignment with clinical monitoring by the one‐stage clotting assay. To evaluate the efficacy and safety of B‐domain‐deleted recombinant factor VIII (BDDrFVIII) was given as bolus injection (BI) or continuous infusion (CI) in haemophilia patients undergoing major surgery. BDDrFVIII was administered by BI or CI per investigator discretion peri‐operatively for at least 6 days. Thirty patients enrolled and were treated with at least one dose of BDDrFVIII. Twenty‐five patients were evaluable for efficacy. Outcomes were favourable against a background of multiple major surgical procedures. All haemostatic efficacy ratings were ‘excellent’ or ‘good’. End‐of‐surgery haemostasis ratings, the primary efficacy endpoint, were excellent for 72% (18/25) and good for 28% (7/25) of patients. Haemostasis ratings following the initial postoperative period were excellent for 92% (23/25) and good for 8% (2/25) of patients. Intra‐operative blood loss was rated as normal in all patients. Thirteen patients had postoperative blood loss; in 10, this was rated as normal. A low frequency of transfusion was reported in both the intra‐operative and postoperative settings. Adverse events (AEs) were consistent with surgery; three were considered related to BDDrFVIII. One patient had a related AE of postoperative haemorrhage. A clinically silent low‐titre inhibitor was detected in one patient, and one patient had a false‐positive inhibitor titre. This study demonstrates that BDDrFVIII is safe and efficacious for surgical prophylaxis in haemophilia A patients undergoing major surgery. |
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Bibliography: | istex:7663630AB4209FCD52FE0F9F61AD16128EC28A5D ArticleID:HAE2239 ark:/67375/WNG-7LTNC14Q-R ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Article-2 ObjectType-Feature-1 |
ISSN: | 1351-8216 1365-2516 |
DOI: | 10.1111/j.1365-2516.2010.02239.x |