Journal of thrombosis and haemostasis : JTH
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J. Thromb. Haemost. · Sep 2020
Clinical TrialLong-term safety and efficacy of N8-GP in previously treated pediatric patients with hemophilia A: Final results from pathfinder5.
N8-GP (turoctocog alfa pegol; Esperoct® , Novo Nordisk A/S, Bagsvaerd, Denmark) is a glycoPEGylated, extended half-life human recombinant factor VIII (FVIII). ⋯ Overall, data from the completed pathfinder5 trial show that long-term (median 4.9 years) N8-GP treatment was efficacious and well tolerated in previously treated pediatric patients with severe hemophilia A.
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J. Thromb. Haemost. · Sep 2020
Case ReportsThromboprophylaxis in a patient with COVID-19 and severe hemophilia A on emicizumab prophylaxis.
COVID-19 can be associated with coagulopathy (CAC, COVID-19-associated coagulopathy) with a high prothrombotic risk based on an intense inflammatory response to viral infection leading to immunothrombosis through different procoagulant pathways. Emerging evidence suggests that the use of heparin in these patients could be associated with lower mortality. ⋯ Although this risk is extremely low, there is a lack of evidence on whether CAC increases the thrombotic risk in patients on emicizumab prophylaxis. We present the case of a patient with severe hemophilia A in prophylaxis treatment with emicizumab; due to the potential thrombotic risk we decided to administer low molecular weight heparin as prophylaxis treatment without any thrombotic or bleeding complications.
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J. Thromb. Haemost. · Sep 2020
Incidence of deep vein thrombosis among non-ICU patients hospitalized for COVID-19 despite pharmacological thromboprophylaxis.
A remarkably high incidence of venous thromboembolism (VTE) has been reported among critically ill patients with COVID-19 assisted in the intensive care unit (ICU). However, VTE burden among non-ICU patients hospitalized for COVID-19 that receive guideline-recommended thromboprophylaxis is unknown. ⋯ DVT may occur among non-ICU patients hospitalized for COVID-19, despite guideline-recommended thromboprophylaxis.
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J. Thromb. Haemost. · Sep 2020
ReviewAn overview of the pathfinder clinical trials program: Long-term efficacy and safety of N8-GP in patients with hemophilia A.
N8-GP (turoctocog alfa pegol, Esperoct® ; Novo Nordisk A/S, Bagsvaerd, Denmark) is a state-of-the-art, extended half-life factor VIII (FVIII) molecule used for prophylactic and on-demand treatment of patients with hemophilia A. The pathfinder clinical trial program, which began with the pathfinder1 trial in 2010, was developed to assess the long-term efficacy and safety of N8-GP in children, adolescents, and adults. ⋯ Here, we provide an overview of the pathfinder clinical development program and summarize key data from the completed pathfinder trials. We also provide perspectives on the future of extended half-life FVIII molecules in the treatment of patients with hemophilia A and describe currently ongoing pathfinder trials.