Ongoing NovoSeven® trials

Recombinant activated factor VII (rFVIIa, 'NovoSeven(R)') was initially developed for the treatment of bleeding in patients with haemophilia and inhibitors, and is currently licensed in most countries worldwide. The mechanism of action suggests that its enhancing effects in haemostasis are limited to the site of injury and that systemic activation of the coagulation cascade does not occur. These properties, together with anecdotal reports of its beneficial effects in different patient populations with severe bleeds, suggest that rFVIIa may be valuable as a general haemostatic agent. In case reports, rFVIIa has been reported to reduce bleeding in patients with liver disease, thrombocytopenia or thrombocytopathia, trauma, those undergoing radical prostatectomy or receiving oral anticoagulant therapy. A number of clinical trials have recently been initiated to collect data on the safety and efficacy of rFVIIa in these patient groups. The beneficial effects of rFVIIa occurring in these studies will support the potential use of rFVIIa as a universal haemostatic agent.