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

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Haemophilia B With Inhibitors; Haemophilia A With Inhibitors; Congenital Bleeding Disorder

Treatments: Drug: activated recombinant human factor VII; Other: factor IX; Drug: factor VIII

Study type: Interventional

Funder types: Industry

Identifiers

NCT01561391

F7HAEM/USA/4/USA

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Continuous infusion

Experimental group

Treatment:

Drug: activated recombinant human factor VII

Drug: activated recombinant human factor VII

Bolus injection

Experimental group

Treatment:

Drug: activated recombinant human factor VII

Drug: activated recombinant human factor VII

Control

Experimental group

Treatment:

Other: factor IX

Drug: factor VIII