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This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) in preventing early haematoma growth in acute Intracerebral Haemorrhage (ICH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| activated recombinant human factor VII | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII | Drug | Starting dose of trial drug 10 mcg/kg, escalating up to five dose tiers: 20 mcg/kg, 40 mcg/kg, 80 mcg/kg, 120 mcg/kg and 160 mcg/kg. Administered within the first 4 hours after the insult |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ICH volume as measured by CT head scans |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | ||
| Occurrence of serious adverse events |
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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 | Parkville | Victoria | 3052 | Australia | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15569871 | Result | Mayer SA, Brun NC, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; Europe/AustralAsia NovoSeven ICH Trial Investigators. Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage. Stroke. 2005 Jan;36(1):74-9. doi: 10.1161/01.STR.0000149628.80251.b8. Epub 2004 Nov 29. | |
| 37870112 | Derived |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo | Drug | Starting dose of trial drug 10 mcg/kg, escalating up to five dose tiers: 20 mcg/kg, 40 mcg/kg, 80 mcg/kg, 120 mcg/kg and 160 mcg/kg. Administered within the first 4 hours after the insult |
|
| Copenhagen |
| Denmark |
| Novo Nordisk Investigational Site | Jyväskylä | 40620 | Finland |
| Novo Nordisk Investigational Site | Heidelberg | 60120 | Germany |
| Novo Nordisk Investigational Site | Roma | 00185 | Italy |
| Novo Nordisk Investigational Site | Singapore | 308443 | Singapore |
| Novo Nordisk Investigational Site | Girona | 17007 | Spain |
| Novo Nordisk Investigational Site | Dawan | Taiwan |
| Novo Nordisk Investigational Site | Newcastle | United Kingdom |
| Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5. |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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