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

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia B
• Interventions: Drug: ALPROLIX®; Drug: N9-GP

• Registration Number: NCT03075670
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-03
• Study Start: 2017-03-07
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-09
• Primary Completion: 2017-12-08
• Study Completion: 2017-12-08
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ALPROLIX®	ALPROLIX®	-
N9-GP	N9-GP	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Incremental recovery at 30 minutes (IR30min)	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
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
Number of adverse events	From time 0 (dosing) up to 240 hours post-dose	Count and % of Adverse events
Terminal half-life (t½)	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
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
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
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
Time of maximum activity (tmax)	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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇭 Zürich, Switzerland