NCT03075670

A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B

A Trial Comparing the Pharmacokinetics of Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Europe and the United States of America. The aim of this trial is to compare the pharmacokinetics (the exposure of the trial drug in the body) of nonacog beta pegol (N9-GP) and ALPROLIX® in patients with haemophilia B.

Conditions

• Congenital Bleeding Disorder
• Haemophilia B

Interventions

Type	Name	Description
DRUG	N9-GP	A single dose of 50 IU/kg for intravenous (i.v.) injection
DRUG	ALPROLIX®	A single dose of 50 IU/kg for intravenous (i.v.) injection

Timeline

• Start date: 2017-03-07
• Primary completion: 2017-12-08
• Completion: 2017-12-08
• First posted: 2017-03-09
• Last updated: 2023-05-26

Locations

12 sites across 3 countries: United States, Germany, Switzerland

Regulatory

• FDA-regulated drug study