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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-000891-42 | EudraCT Number |
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This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two administrations of activated recombinant human factor VII in haemophilia patients in a non bleeding state.
The TEG® parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM® parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose | Experimental |
| |
| Medium dose | Experimental |
| |
| High dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII | Drug | Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection) |
|
| Measure | Description | Time Frame |
|---|---|---|
| TEG® (Thromboelastography) parameters after dosing of trial product | ||
| ROTEM® (Thromboelastometry) parameters after dosing of trial product |
| Measure | Description | Time Frame |
|---|---|---|
| TEG® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII | ||
| ROTEM® parameters obtained from blood samples spiked ex vivo with activated recombinant human factor VII |
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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 |
|---|---|---|---|---|---|---|
| Lille | 59037 | France | ||||
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Serious adverse events and non-serious adverse events |
| München |
| 80336 |
| Germany |
| Tel Litwinsky | 52621 | Israel |
| 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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