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

• Status: Completed
• Trial end date: 2017-12-08
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• Male, aged 18-70 years (both inclusive) at the time of signing informed consent

• Patients with the diagnosis of congenital haemophilia B with factor IX activity below or equal to 2%, based on medical records

• History of more than 150 exposures days to any factor IX containing products

Exclusion Criteria:

• Known history of factor IX inhibitors

• Inhibitors to factor IX (above or equal to 0.6 BU) at screening measured by the Nijmegen modified Bethesda method

• Immunocompromised (CD4+ T cells below or equal to 200/μL)

• Known congenital or acquired coagulation disorders other than haemophilia B

• Body mass index above 35 kg/m^²