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

Study Overview
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Brief Summary
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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.

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

Conditions
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Congenital Bleeding Disorder, Haemophilia B

Intervention / Treatment
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* Drug: N9-GP
* Drug: ALPROLIX®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N9-GP<br> | Drug: N9-GP<br>* A single dose of 50 IU/kg for intravenous (i.v.) injection<br>|
| Active Comparator: ALPROLIX®<br> | Drug: ALPROLIX®<br>* A single dose of 50 IU/kg for intravenous (i.v.) injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the factor IX activity-time curve from 0 to infinity dose-normalised to 50 IU/kg | Calculated based on plasma FIX activity measured in blood | From time 0 (dosing) up to 240 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum activity dose-normalised to 50 IU/kg (Cmax,norm) | Calculated based on plasma FIX activity measured in blood | From time 0 (dosing) up to 240 hours post-dose | 
| Incremental recovery at 30 minutes (IR30min) | Calculated based on plasma FIX activity measured in blood | At 30 minutes | 
| Terminal half-life (t½) | Calculated based on plasma FIX activity measured in blood | From time 0 (dosing) up to 240 hours post-dose | 
| Clearance (CL) | Calculated based on plasma FIX activity measured in blood | From time 0 (dosing) up to 240 hours post-dose | 
| Area under the activity-time curve | Calculated based on plasma FIX activity measured in blood | From time 0 (dosing) up to 240 hours post-dose | 
| Maximum activity (Cmax) | Calculated based on plasma FIX activity measured in blood | From time 0 (dosing) up to 240 hours post-dose | 
| Activity at 30 minutes (C30min) | Calculated based on plasma FIX activity measured in blood | at 30 minutes | 
| Activity at 168 hours (C168h) | Calculated based on plasma FIX activity measured in blood | At 168 hours | 
| Incremental recovery at maximum activity (IRCmax) | Calculated based on plasma FIX activity measured in blood | From time 0 (dosing) up to 240 hours post-dose | 
| Time of maximum activity (tmax) | Calculated based on plasma FIX activity measured in blood | From time 0 (dosing) up to 240 hours post-dose | 
| Apparent volume of distribution during terminal phase (Vz) | Calculated based on plasma FIX activity measured in blood | From time 0 (dosing) up to 240 hours post-dose | 
| Apparent volume of distribution at steady-state (Vss) | Calculated based on plasma FIX activity measured in blood | From time 0 (dosing) up to 240 hours post-dose | 
| Mean residence time (MRT) | Calculated based on plasma FIX activity measured in blood | From time 0 (dosing) up to 240 hours post-dose | 
| Terminal elimination rate constant | Calculated based on plasma FIX activity measured in blood | From time 0 (dosing) up to 240 hours post-dose | 
| Area under the activity-time curve from 0 to infinity | Calculated based on plasma FIX activity measured in blood | From time 0 (dosing) up to 240 hours post-dose | 
| Area under the activity-time curve from 0 to t last | Calculated based on plasma FIX activity measured in blood | From time 0 (dosing) up to 240 hours post-dose | 
| Number of adverse events | Count and % of Adverse events | From time 0 (dosing) up to 240 hours post-dose |