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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011085-28 | EudraCT Number | ||
| 090857 | Registry Identifier | JAPIC |
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This trial is conducted in Europe, Japan and the United States of America (USA).
The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of Pegylated Recombinant Factor IX (nonacog beta pegol) in Non-Bleeding Patients with Haemophilia B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25U/kg | Experimental |
| |
| 50U/kg | Experimental |
| |
| 100U/kg | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nonacog beta pegol | Drug | Cohort to receive a single dose of 25U/kg nonacog beta pegol administered intravenously (into the vein) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events (AEs), Serious Adverse Events (SAEs) and Medical Events of Special Interests (MESIs) reported during the trial period | assessed up to five weeks after trial product administration | |
| Antibody formation against 40K PEG-rFIX and test for inhibitors (Bethesda) | assessed up to five weeks after trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC, CL, T½, Incremental recovery (first sample) from 0 to 48 hours after trial product administration | assessed up to five weeks after trial product administration | |
| AUC, CL, T½, Incremental recovery (first sample) from 0 to 168 hours after trial product administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Cincinnati | Ohio | 45229 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21555744 | Background | Negrier C, Knobe K, Tiede A, Giangrande P, Moss J. Enhanced pharmacokinetic properties of a glycoPEGylated recombinant factor IX: a first human dose trial in patients with hemophilia B. Blood. 2011 Sep 8;118(10):2695-701. doi: 10.1182/blood-2011-02-335596. Epub 2011 May 9. | |
| 22998153 | Background | Collins PW, Moss J, Knobe K, Groth A, Colberg T, Watson E. Population pharmacokinetic modeling for dose setting of nonacog beta pegol (N9-GP), a glycoPEGylated recombinant factor IX. J Thromb Haemost. 2012 Nov;10(11):2305-12. doi: 10.1111/jth.12000. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| nonacog beta pegol | Drug | Cohort to receive a single dose of 50U/kg nonacog beta pegol administered intravenously (into the vein) |
|
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| nonacog beta pegol | Drug | Cohort to receive a single dose of 100U/kg nonacog beta pegol administered intravenously (into the vein) |
|
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| assessed up to five weeks after trial product administration |
| Portland |
| Oregon |
| 97239 |
| United States |
| Novo Nordisk Investigational Site | Richmond | Virginia | 23219 | United States |
| Novo Nordisk Investigational Site | Copenhagen | 2100 | Denmark |
| Novo Nordisk Investigational Site | Le Kremlin-Bicêtre | 94270 | France |
| Novo Nordisk Investigational Site | Lyon | 69003 | France |
| Novo Nordisk Investigational Site | Berlin | 10249 | Germany |
| Novo Nordisk Investigational Site | Bonn | 53127 | Germany |
| Novo Nordisk Investigational Site | Frankfurt/M. | 60590 | Germany |
| Novo Nordisk Investigational Site | Hanover | 30625 | Germany |
| Novo Nordisk Investigational Site | Kashihara-shi, Nara | 634 8522 | Japan |
| Novo Nordisk Investigational Site | Nagoya-shi, Aichi | 466 8560 | Japan |
| Novo Nordisk Investigational Site | Nishinomiya-shi | 663 8051 | Japan |
| Novo Nordisk Investigational Site | Madrid | 28046 | Spain |
| Novo Nordisk Investigational Site | Stockholm | 171 76 | Sweden |
| Novo Nordisk Investigational Site | London | NW3 2QG | United Kingdom |
| Novo Nordisk Investigational Site | London | SE1 7EH | United Kingdom |
| Novo Nordisk Investigational Site | Manchester | M13 9WL | United Kingdom |
| Novo Nordisk Investigational Site | Oxford | OX3 7LJ | United Kingdom |
| 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 |
|---|---|
| C000592276 | nonacog beta pegol |
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