Congenital Bleeding Disorder, Haemophilia B
Conditions
Brief 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.
Interventions
DRUGN9-GP
A single dose of 50 IU/kg for intravenous (i.v.) injection
DRUGALPROLIX®
A single dose of 50 IU/kg for intravenous (i.v.) injection
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the factor IX activity-time curve from 0 to infinity dose-normalised to 50 IU/kg | From time 0 (dosing) up to 240 hours post-dose | Calculated based on plasma FIX activity measured in blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Terminal half-life (t½) | From time 0 (dosing) up to 240 hours post-dose | Calculated based on plasma FIX activity measured in blood |
| Maximum activity dose-normalised to 50 IU/kg (Cmax,norm) | From time 0 (dosing) up to 240 hours post-dose | Calculated based on plasma FIX activity measured in blood |
| Clearance (CL) | From time 0 (dosing) up to 240 hours post-dose | Calculated based on plasma FIX activity measured in blood |
| Area under the activity-time curve | From time 0 (dosing) up to 240 hours post-dose | Calculated based on plasma FIX activity measured in blood |
| Maximum activity (Cmax) | From time 0 (dosing) up to 240 hours post-dose | Calculated based on plasma FIX activity measured in blood |
| Activity at 30 minutes (C30min) | at 30 minutes | Calculated based on plasma FIX activity measured in blood |
| Activity at 168 hours (C168h) | At 168 hours | Calculated based on plasma FIX activity measured in blood |
| Incremental recovery at maximum activity (IRCmax) | From time 0 (dosing) up to 240 hours post-dose | Calculated based on plasma FIX activity measured in blood |
| Incremental recovery at 30 minutes (IR30min) | At 30 minutes | Calculated based on plasma FIX activity measured in blood |
| Apparent volume of distribution during terminal phase (Vz) | From time 0 (dosing) up to 240 hours post-dose | Calculated based on plasma FIX activity measured in blood |
| Apparent volume of distribution at steady-state (Vss) | From time 0 (dosing) up to 240 hours post-dose | Calculated based on plasma FIX activity measured in blood |
| Mean residence time (MRT) | From time 0 (dosing) up to 240 hours post-dose | Calculated based on plasma FIX activity measured in blood |
| Terminal elimination rate constant | From time 0 (dosing) up to 240 hours post-dose | Calculated based on plasma FIX activity measured in blood |
| Area under the activity-time curve from 0 to infinity | From time 0 (dosing) up to 240 hours post-dose | Calculated based on plasma FIX activity measured in blood |
| Area under the activity-time curve from 0 to t last | From time 0 (dosing) up to 240 hours post-dose | Calculated based on plasma FIX activity measured in blood |
| Number of adverse events | From time 0 (dosing) up to 240 hours post-dose | Count and % of Adverse events |
| Time of maximum activity (tmax) | From time 0 (dosing) up to 240 hours post-dose | Calculated based on plasma FIX activity measured in blood |
Countries
Germany, Switzerland, United States
Outcome results
None listed