Author: DMOSZYNSKA, A.; KULICZKOWSKI, K.; HELLMANN, A.; TRELINSKI, J.; KLOCZKO, J.; BAGLIN, T.; HAY, C.; O’SHAUGHNESSY, D.; ZAWILSKA, K.; MAKRIS, M.; SHAIKHâ€ZAIDI, R.; GASCOIGNE, E.; DASH, C.
Title: Clinical assessment of Optivate(®), a highâ€purity concentrate of factor VIII with von Willebrand factor, in the management of patients with haemophilia A Cord-id: 68bpxuba Document date: 2011_3_4
ID: 68bpxuba
Snippet: Summary. Factor VIII (FVIII) concentrates have revolutionized the treatment of patients with haemophilia A. Concerns over the transmission of viral infections through these products have been addressed through stringent, donorâ€screening procedures and robust antiviral manufacturing steps. Bio Products Laboratory has developed a highâ€purity FVIII product with von Willebrand factor, Optivate(®). Its safety, tolerability and efficacy as prophylaxis and treatment of bleeds have been established
Document: Summary. Factor VIII (FVIII) concentrates have revolutionized the treatment of patients with haemophilia A. Concerns over the transmission of viral infections through these products have been addressed through stringent, donorâ€screening procedures and robust antiviral manufacturing steps. Bio Products Laboratory has developed a highâ€purity FVIII product with von Willebrand factor, Optivate(®). Its safety, tolerability and efficacy as prophylaxis and treatment of bleeds have been established in longâ€term studies. Seventy previously treated patients with severe haemophilia A, with ≥20 exposure days, were recruited into two longâ€term, multicentre, openâ€label studies. The protocols were virtually identical. Patients received Optivate(®) either prophylactically or onâ€demand. A mean of 159.0 EDs were experienced over 11 320 infusions. Under both conditions, Optivate(®) was well tolerated. Only 10% of patients experienced a treatmentâ€related adverse event; the most commonly reported were headache (4% of patients) and dizziness (3% of patients). The mean number of bleeds/patient over the 2 year treatment period was 23.5 during prophylactic use and 70.4 during onâ€demand use. In patients treated prophylactically, clinical responses to breakthrough bleeds were rated by physicians as excellent or good and as very helpful or helpful by patients in 95% of bleeds. Clinical responses for onâ€demand patients were rated as excellent or good by physicians and helpful or very helpful by the patients for 91% of bleeds. There were no viral transmissions or inhibitors. The studies confirm the clinical efficacy and safety of Optivate(®) in both prophylactic and onâ€demand management of patients with haemophilia A.
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