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

Novo Nordisk A/S15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congenital Bleeding Disorder Haemophilia B

Interventions

N9-GPDRUG

A single dose of 50 IU/kg for intravenous (i.v.) injection

ALPROLIX®DRUG

A single dose of 50 IU/kg for intravenous (i.v.) injection

Eligibility

Sex: MALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (12)

Novo Nordisk Investigational Site

Phoenix, Arizona, United States

Novo Nordisk Investigational Site

Chicago, Illinois, United States

Novo Nordisk Investigational Site

Peoria, Illinois, United States