NCT01561391

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Bleeding Disorder
• Haemophilia A With Inhibitors
• Haemophilia B With Inhibitors

Interventions

Type	Name	Description
DRUG	activated recombinant human factor VII	Infused continuously at 50 mcg/kg/hr through Day 5 then at 25 mcg/kg/hr on Days 6 to10.
DRUG	activated recombinant human factor VII	Injected every 2 hours during surgery through Day 5, then every 4 hours for Days 6 to 10.
OTHER	factor IX	Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.
DRUG	factor VIII	Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.

Timeline

• Start date: 1998-04-01
• Primary completion: 2004-05-01
• Completion: 2004-05-01
• First posted: 2012-03-23
• Last updated: 2023-12-29

Locations

14 sites across 1 country: United States