NCT02141074

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

An Open-label Single-arm Multicentre Non-controlled Phase 3 a Trial Investigating Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Prophylaxis and Treatment of Bleeding Episodes in Previously Untreated Patients With Haemophilia B (FIX Activity Below or Equal to 2 Percent)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 0 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.

Conditions

• Congenital Bleeding Disorder
• Haemophilia B

Interventions

Type	Name	Description
DRUG	nonacog beta pegol	For intravenous (i.v.) injection. A single dose of 40 U/kg, unless the bleeding episode is severe in which case it should be treated with 80 U/kg.

Timeline

• Start date: 2014-07-02
• Primary completion: 2022-10-27
• Completion: 2022-10-27
• First posted: 2014-05-19
• Last updated: 2025-12-23
• Results posted: 2023-12-29

Locations

93 sites across 24 countries: United States, Algeria, Argentina, Australia, Austria, Bulgaria, Canada, France, Germany, Greece, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Portugal, Romania, Serbia, Spain, Taiwan, Thailand, Ukraine, United Kingdom