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Phase 3 Study of Recombinant von Willebrand Factor in Patients With Severe von Willebrand Disease Who Are Undergoing Elective Surgery.
Journal of Thrombosis and Haemostasis : JTH 2018 October 26
BACKGROUND: Recombinant von Willebrand factor (rVWF) has demonstrated efficacy for on-demand treatment of bleeding in severe von Willebrand disease (VWD), warranting evaluation in the surgical setting.
OBJECTIVES: This study (NCT02283268) evaluated the hemostatic efficacy/safety profile of rVWF, with/without recombinant factor VIII (rFVIII), in patients with severe VWD undergoing surgery.
PATIENTS/METHODS: Patients received rVWF 40-60 IU/kg, VWF ristocetin cofactor activity was measured 12-24 hours before surgery. If endogenous FVIII activity (FVIII:C) target levels were achieved 3 hours before surgery, rVWF was administered alone 1 hour before surgery; rVWF was coadministered with rFVIII if target endogenous FVIII levels were not achieved. rVWF was infused postoperatively to maintain target trough levels. Overall and intraoperative hemostatic efficacy, the pharmacodynamics of rVWF administration and the incidence of adverse events (AEs) were assessed.
RESULTS: All patients treated with rVWF for major (n=10), minor (n=4), and oral (n=1) surgery had overall and intraoperative hemostatic efficacy ratings of excellent (73.3% and 86.7%) or good (26.7% and 13.3%). Most rVWF infusions (89.4%) were administered alone, resulting in hemostatically effective levels of endogenous FVIII within 6 hours, that were sustained for 72-96 hours; 70% (n=7/10) of major surgeries were performed without rFVIII coadministration. Six patients reported 12 treatment-emergent AEs. Two patients each had 1 serious AE: diverticulitis (not treatment related) and deep vein thrombosis (sponsor assessed as possibly treatment-related). No severe allergic reactions or inhibitory antibodies were reported.
CONCLUSIONS: These data support the efficacy and safety profile of rVWF in patients with severe VWD undergoing elective surgery. This article is protected by copyright. All rights reserved.
OBJECTIVES: This study (NCT02283268) evaluated the hemostatic efficacy/safety profile of rVWF, with/without recombinant factor VIII (rFVIII), in patients with severe VWD undergoing surgery.
PATIENTS/METHODS: Patients received rVWF 40-60 IU/kg, VWF ristocetin cofactor activity was measured 12-24 hours before surgery. If endogenous FVIII activity (FVIII:C) target levels were achieved 3 hours before surgery, rVWF was administered alone 1 hour before surgery; rVWF was coadministered with rFVIII if target endogenous FVIII levels were not achieved. rVWF was infused postoperatively to maintain target trough levels. Overall and intraoperative hemostatic efficacy, the pharmacodynamics of rVWF administration and the incidence of adverse events (AEs) were assessed.
RESULTS: All patients treated with rVWF for major (n=10), minor (n=4), and oral (n=1) surgery had overall and intraoperative hemostatic efficacy ratings of excellent (73.3% and 86.7%) or good (26.7% and 13.3%). Most rVWF infusions (89.4%) were administered alone, resulting in hemostatically effective levels of endogenous FVIII within 6 hours, that were sustained for 72-96 hours; 70% (n=7/10) of major surgeries were performed without rFVIII coadministration. Six patients reported 12 treatment-emergent AEs. Two patients each had 1 serious AE: diverticulitis (not treatment related) and deep vein thrombosis (sponsor assessed as possibly treatment-related). No severe allergic reactions or inhibitory antibodies were reported.
CONCLUSIONS: These data support the efficacy and safety profile of rVWF in patients with severe VWD undergoing elective surgery. This article is protected by copyright. All rights reserved.
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