NCT01333111

Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients

A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC-0156-0000-0009 When Used for Treatment and Prophylaxis of Bleeding Episodes in Patients With Haemophilia B

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (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, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.

Conditions

• Congenital Bleeding Disorder
• Haemophilia B

Interventions

Type	Name	Description
DRUG	nonacog beta pegol	One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience
DRUG	nonacog beta pegol	One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience
DRUG	nonacog beta pegol	Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode

Timeline

• Start date: 2011-04-27
• Primary completion: 2013-03-31
• Completion: 2013-03-31
• First posted: 2011-04-11
• Last updated: 2017-07-28
• Results posted: 2017-07-28

Locations

43 sites across 15 countries: United States, Canada, France, Germany, Hungary, Italy, Japan, Malaysia, Netherlands, North Macedonia, Russia, South Africa, Thailand, Turkey (Türkiye), United Kingdom