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This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults | Experimental |
| |
| Paediatric | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII | Drug | A single bolus dose is administered. Injected intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration curve from 0-12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| CL, the total body clearance | ||
| Cmax, the maximum concentration | ||
| tmax, the time to maximum concentration |
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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 | Bremen | 28205 | Germany | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15230949 | Result | Villar A, Aronis S, Morfini M, Santagostino E, Auerswald G, Thomsen HF, Erhardtsen E, Giangrande PL. Pharmacokinetics of activated recombinant coagulation factor VII (NovoSeven) in children vs. adults with haemophilia A. Haemophilia. 2004 Jul;10(4):352-9. doi: 10.1111/j.1365-2516.2004.00925.x. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| activated recombinant human factor VII | Drug | A random order of a low/high dose of single dose is administered during two PK-assessment periods separated by a washout period of 48 hours to one month. Injected intravenously |
|
| t1/2, the terminal half-life |
| Area under the concentration curve from time 0-infinity |
| Vss, the apparent volume of distribution at steady state |
| Adverse events |
| Frankfurt |
| 60590 |
| Germany |
| Novo Nordisk Investigational Site | Athens | GR-11527 | Greece |
| Novo Nordisk Investigational Site | Florence | 50134 | Italy |
| Novo Nordisk Investigational Site | Milan | 20124 | Italy |
| Novo Nordisk Investigational Site | Madrid | 28046 | Spain |
| Novo Nordisk Investigational Site | London | WC1N 3JH | United Kingdom |
| Novo Nordisk Investigational Site | Oxford | OX3 7LJ | United Kingdom |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| 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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