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

Completed · Phase 1

Conditions studied: Congenital Bleeding Disorder, Haemophilia B

In brief

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.

Key facts

Study ID

NCT03075670

Run by

Novo Nordisk A/S

People needed

15

Starts

2017-03-07

Expected to finish

2017-12-08

Last updated by the study team

2023-05-26

Who can join

Age: 18 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Phoenix, Arizona, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Peoria, Illinois, United States
• Novo Nordisk Investigational Site — East Lansing, Michigan, United States
• Novo Nordisk Investigational Site — Rochester, Minnesota, United States
• Novo Nordisk Investigational Site — Oklahoma City, Oklahoma, United States
• Novo Nordisk Investigational Site — Philadelphia, Pennsylvania, United States
• Novo Nordisk Investigational Site — Berlin, Germany
• Novo Nordisk Investigational Site — Duisburg, Germany
• Novo Nordisk Investigational Site — Hanover, Germany
• Novo Nordisk Investigational Site — Mörfelden-Walldorf, Germany
• Novo Nordisk Investigational Site — Zurich, Switzerland

Full record on ClinicalTrials.gov

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