NCT01386528

Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B

An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Patients With Haemophilia B

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 13 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.

Conditions

• Congenital Bleeding Disorder
• Haemophilia B

Interventions

Type	Name	Description
DRUG	nonacog beta pegol	The patients will receive nonacog beta pegol at screening just prior to and during surgical intervention, administered intravenously (into the vein).

Timeline

• Start date: 2012-06-07
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-07-01
• Last updated: 2017-08-23
• Results posted: 2017-07-24

Locations

41 sites across 17 countries: United States, Austria, France, Germany, Greece, Italy, Japan, Malaysia, Netherlands, North Macedonia, Romania, South Africa, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom