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

Congenital Bleeding Disorder Clinical Trial

— paradigm™7  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075670
• Other study ID #: NN7999-4260
• Secondary ID: 2016-001149-25U1
• Status: Completed
• Phase: Phase 1
• Start date: March 7, 2017
• Est. completion date: December 8, 2017

Study information

• Verified date: May 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 8, 2017
• Est. primary completion date: December 8, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia B
• Hemophilia A
• Hemophilia B
• Hemostatic Disorders

Intervention

Drug:
• N9-GP
A single dose of 50 IU/kg for intravenous (i.v.) injection
• ALPROLIX®
A single dose of 50 IU/kg for intravenous (i.v.) injection

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Duisburg
Germany	Novo Nordisk Investigational Site	Hannover
Germany	Novo Nordisk Investigational Site	Mörfelden-Walldorf
Switzerland	Novo Nordisk Investigational Site	Zürich
United States	Novo Nordisk Investigational Site	Chicago	Illinois
United States	Novo Nordisk Investigational Site	East Lansing	Michigan
United States	Novo Nordisk Investigational Site	Oklahoma City	Oklahoma
United States	Novo Nordisk Investigational Site	Peoria	Illinois
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Phoenix	Arizona
United States	Novo Nordisk Investigational Site	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Incremental recovery at 30 minutes (IR30min)	Calculated based on plasma FIX activity measured in blood	At 30 minutes
Secondary	Terminal half-life (t½)	Calculated based on plasma FIX activity measured in blood	From time 0 (dosing) up to 240 hours post-dose
Secondary	Clearance (CL)	Calculated based on plasma FIX activity measured in blood	From time 0 (dosing) up to 240 hours post-dose
Secondary	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
Secondary	Maximum activity (Cmax)	Calculated based on plasma FIX activity measured in blood	From time 0 (dosing) up to 240 hours post-dose
Secondary	Activity at 30 minutes (C30min)	Calculated based on plasma FIX activity measured in blood	at 30 minutes
Secondary	Activity at 168 hours (C168h)	Calculated based on plasma FIX activity measured in blood	At 168 hours
Secondary	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
Secondary	Time of maximum activity (tmax)	Calculated based on plasma FIX activity measured in blood	From time 0 (dosing) up to 240 hours post-dose
Secondary	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
Secondary	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
Secondary	Mean residence time (MRT)	Calculated based on plasma FIX activity measured in blood	From time 0 (dosing) up to 240 hours post-dose
Secondary	Terminal elimination rate constant	Calculated based on plasma FIX activity measured in blood	From time 0 (dosing) up to 240 hours post-dose
Secondary	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
Secondary	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
Secondary	Number of adverse events	Count and % of Adverse events	From time 0 (dosing) up to 240 hours post-dose