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

Status:	Completed
Conditions:	Hematology, Hematology
Therapuetic Areas:	Hematology
Healthy:	No
Age Range:	5 - Any
Updated:	1/13/2017
Start Date:	April 1998
End Date:	May 2004

An Open-Label, Randomized, Parallel, Multicenter Trial Comparing the Safety and Efficacy of rFVIIa When Administered as i.v. Bolus or i.v. Continuous Infusion to Hemophiliacs With Inhibitors During and After Major Surgery

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.

Inclusion Criteria:

- Have haemophilia A or B with inhibitors to factor VIII or IX, respectively

- Have had a historical inhibitor level of at least five Bethesda units or have had an
inadequate haemostatic response to 250 U/kg of factor VIII or IX or have had an
inadequate response to FEIBA

- Require pre-planned major surgery in hospital

Exclusion Criteria:

- Have participated in or have been treated with any investigational drug other than
activated recombinant human factor VII within the last thirty days

- Have been treated with any haemostatic agent, including rFVIIa, within 48 hours of
preoperative dose

- Have any haemostatic disorder other than haemophilia

We found this trial at

sites

Novo Nordisk Investigational Site

New Orleans, Louisiana 70112

from

New Orleans, LA