Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery

Phase 4 Completed 36 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.

Timeline

Start: 1998-04
Primary completion: 2004-05
Completion: 2004-05

Publications

Results Pruthi RK, Mathew P, Valentino LA, Sumner MJ, Seremetis S, Hoots WK; NovoSeven in Surgery Study Investigators. Haemostatic efficacy and safety of bolus and continuous infusion of recombinant factor VIIa are comparable in haemophilia patients with inhibitors undergoing major surgery. Results from an open-label, randomized, multicenter trial. Thromb Haemost. 2007 Oct;98(4):726-32.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	activated recombinant human factor VII	Protein / enzyme biologic	25 ug/kg	Intravenous
Subject	activated recombinant human factor VII	Protein / enzyme biologic	90 ug/kg	Intravenous
Background	Factor VIII	Protein / enzyme biologic	—	—

Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery

Summary

Timeline

Publications

Drugs

Indications