NCT01467427

Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.

Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 0 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.

Conditions

• Congenital Bleeding Disorder
• Haemophilia B

Interventions

Type	Name	Description
DRUG	nonacog beta pegol	A single dose of 40 U/kg will be administered intravenously, i.v. (into the vein) once weekly.

Timeline

• Start date: 2012-05-16
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2011-11-08
• Last updated: 2025-12-23
• Results posted: 2017-11-17

Locations

51 sites across 12 countries: United States, Brazil, Canada, Croatia, France, Germany, Italy, Japan, Malaysia, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study