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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
First received
Last updated
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
Health authority
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

Study Design


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
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