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

Completed · Phase 4

Conditions studied: Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

In brief

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.

Key facts

Study ID

NCT01561391

Run by

Novo Nordisk A/S

People needed

36

Starts

1998-04-01

Expected to finish

2004-05-01

Last updated by the study team

2023-12-29

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — New Orleans, Louisiana, United States
• Novo Nordisk Investigational Site — Boston, Massachusetts, United States
• Novo Nordisk Investigational Site — Rochester, Minnesota, United States
• Novo Nordisk Investigational Site — New Brunswick, New Jersey, United States
• Novo Nordisk Investigational Site — Albuquerque, New Mexico, United States
• Novo Nordisk Investigational Site — New York, New York, United States
• Novo Nordisk Investigational Site — Chapel Hill, North Carolina, United States
• Novo Nordisk Investigational Site — Hershey, Pennsylvania, United States
• Novo Nordisk Investigational Site — Philadelphia, Pennsylvania, United States
• Novo Nordisk Investigational Site — Philadelphia, Pennsylvania, United States
• Novo Nordisk Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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