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

Phase 4

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia B With Inhibitors; Haemophilia A With Inhibitors
• Interventions: Drug: activated recombinant human factor VII; Other: factor IX; Drug: factor VIII

• Registration Number: NCT01561391
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-04
• Primary Completion: 2004-05
• Study Completion: 2004-05
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-23
• Status Verified: 2017-01
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2023-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bolus injection	activated recombinant human factor VII	-
Continuous infusion	activated recombinant human factor VII	-
Control	factor IX	-
Control	factor VIII	-

Primary Outcome Measures

Name	Time	Method
Presence and maintenance of haemostasis
Changes in FVII:C (Factor VII clotting activity) levels following administration of activated recombinant human factor VII

Secondary Outcome Measures

Name	Time	Method
Changes in coagulation-related parameters
Adverse Events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Houston, Texas, United States