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This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) for preventing early hematoma growth in acute Intracerebral Hemorrhage (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 | Subjects will be randomised to receive a single intravenous dose of either 5, 20, 40 and 80 mcg/kg body weight. Administered within the first 4 hours after the insult |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of a treatment-related serious adverse event (SAE) |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | ||
| Change in ICH volume as measured by CT head scans |
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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 | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Mayer SA, Brun NC, Broderick J, Diringer MN, Davis SM, Steiner T. Safety and Preliminary Efficacy of Recombinant Coagulation Factor VII in Patients with Acute Intracerebral Hemorrhage. Stroke 2004; 35: 322 | ||
| 18239180 | Result | Diringer MN, Skolnick BE, Mayer SA, Steiner T, Davis SM, Brun NC, Broderick JP. Risk of thromboembolic events in controlled trials of rFVIIa in spontaneous intracerebral hemorrhage. Stroke. 2008 Mar;39(3):850-6. doi: 10.1161/STROKEAHA.107.493601. Epub 2008 Jan 31. | |
| 16757825 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo | Drug | Subjects will be randomised to receive a single intravenous dose. Administered within the first 4 hours after the insult |
|
| Result |
| Mayer SA, Brun NC, Broderick J, Davis SM, Diringer MN, Skolnick BE, Steiner T; United States NovoSeven ICH Trial Investigators. Recombinant activated factor VII for acute intracerebral hemorrhage: US phase IIA trial. Neurocrit Care. 2006;4(3):206-14. doi: 10.1385/NCC:4:3:206. |
| 37870112 | Derived | 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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