NCT01395810

Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773

Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 13 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B. This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773 (NCT01386528/paradigm™ 3).

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

Timeline

• Start date: 2012-04-15
• Primary completion: 2014-03-30
• Completion: 2014-03-30
• First posted: 2011-07-18
• Last updated: 2018-05-09
• Results posted: 2018-05-09

Locations

49 sites across 18 countries: United States, Austria, France, Germany, Greece, Italy, Japan, Malaysia, Netherlands, North Macedonia, Romania, Russia, South Africa, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom