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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001149-25 | EudraCT Number | ||
| U1111-1180-7154 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N9-GP | Experimental |
| |
| ALPROLIX® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N9-GP | Drug | A single dose of 50 IU/kg for intravenous (i.v.) injection |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Phoenix | Arizona | 85016-7710 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31011711 | Derived | Escuriola Ettingshausen C, Hegemann I, Simpson ML, Cuker A, Kulkarni R, Pruthi RK, Garly ML, Meldgaard RM, Persson P, Klamroth R. Favorable pharmacokinetics in hemophilia B for nonacog beta pegol versus recombinant factor IX-Fc fusion protein: A randomized trial. Res Pract Thromb Haemost. 2019 Mar 23;3(2):268-276. doi: 10.1002/rth2.12192. eCollection 2019 Apr. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ALPROLIX® |
| Drug |
A single dose of 50 IU/kg for intravenous (i.v.) injection |
|
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 |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Novo Nordisk Investigational Site | Peoria | Illinois | 61615 | United States |
| Novo Nordisk Investigational Site | East Lansing | Michigan | 48823 | United States |
| Novo Nordisk Investigational Site | Rochester | Minnesota | 55905-0001 | United States |
| Novo Nordisk Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Novo Nordisk Investigational Site | Berlin | 10249 | Germany |
| Novo Nordisk Investigational Site | Duisburg | 47051 | Germany |
| Novo Nordisk Investigational Site | Hanover | 30159 | Germany |
| Novo Nordisk Investigational Site | Mörfelden-Walldorf | 64546 | Germany |
| Novo Nordisk Investigational Site | Zurich | 8091 | Switzerland |
| ID | Term |
|---|---|
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
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| ID | Term |
|---|---|
| C000599709 | factor IX Fc fusion protein |
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