Congenital Bleeding Disorder Clinical Trial
— paradigm™7Official title:
A Trial Comparing the Pharmacokinetics of Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
Verified date | May 2023 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
United States, Germany, Switzerland,
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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