Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2004-004202-24 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in Asia, Europe, Middle East, North America, Oceania, and South America.
The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding. It is expected that more patients will recover without severe permanent disability after acute treatment with Recombinant Factor VIIa by reducing further intracerebral bleeding.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eptacog alfa (activated) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Reducing disability and improving clinical outcome | After 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reducing mortality | ||
| Reducing hematoma growth |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Birmingham | Alabama | 35209 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18580208 | Result | Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec. | |
| 18480205 | Result | Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; FAST Trial Investigators. Efficacy and safety of recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2008 May 15;358(20):2127-37. doi: 10.1056/NEJMoa0707534. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| Mobile |
| Alabama |
| 36617 |
| United States |
| Novo Nordisk Investigational Site | Phoenix | Arizona | 85013 | United States |
| Novo Nordisk Investigational Site | Fort Smith | Arkansas | 72901 | United States |
| Novo Nordisk Investigational Site | Los Angeles | California | 90024 | United States |
| Novo Nordisk Investigational Site | Oceanside | California | 92056 | United States |
| Novo Nordisk Investigational Site | Orange | California | 92868-4280 | United States |
| Novo Nordisk Investigational Site | Sacramento | California | 95816 | United States |
| Novo Nordisk Investigational Site | San Diego | California | 92103 | United States |
| Novo Nordisk Investigational Site | San Francisco | California | 94110-3594 | United States |
| Novo Nordisk Investigational Site | San Francisco | California | 94143-0780 | United States |
| Novo Nordisk Investigational Site | Stanford | California | 94305 | United States |
| Novo Nordisk Investigational Site | Denver | Colorado | 80204 | United States |
| Novo Nordisk Investigational Site | Denver | Colorado | 80262 | United States |
| Novo Nordisk Investigational Site | Englewood | Colorado | 80113 | United States |
| Novo Nordisk Investigational Site | Hartford | Connecticut | 06102 | United States |
| Novo Nordisk Investigational Site | Washington D.C. | District of Columbia | 20010 | United States |
| Novo Nordisk Investigational Site | Jacksonville | Florida | 32209 | United States |
| Novo Nordisk Investigational Site | Melbourne | Florida | 32901 | United States |
| Novo Nordisk Investigational Site | Tallahassee | Florida | 32308 | United States |
| Novo Nordisk Investigational Site | Tampa | Florida | 33606 | United States |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30320 | United States |
| Novo Nordisk Investigational Site | Augusta | Georgia | 30912-3260 | United States |
| Novo Nordisk Investigational Site | Decatur | Georgia | 33033 | United States |
| Novo Nordisk Investigational Site | Honolulu | Hawaii | 96813 | United States |
| Novo Nordisk Investigational Site | Chicago | Illinois | 60611 | United States |
| Novo Nordisk Investigational Site | Chicago | Illinois | 60612 | United States |
| Novo Nordisk Investigational Site | Maywood | Illinois | 60153 | United States |
| Novo Nordisk Investigational Site | Peoria | Illinois | 61637 | United States |
| Novo Nordisk Investigational Site | Fort Wayne | Indiana | 46805 | United States |
| Novo Nordisk Investigational Site | Indianapolis | Indiana | 46260 | United States |
| Novo Nordisk Investigational Site | Iowa City | Iowa | 52242 | United States |
| Novo Nordisk Investigational Site | Lexington | Kentucky | 40536 | United States |
| Novo Nordisk Investigational Site | Louisville | Kentucky | 40202 | United States |
| Novo Nordisk Investigational Site | Baltimore | Maryland | 21287 | United States |
| Novo Nordisk Investigational Site | Boston | Massachusetts | 02118 | United States |
| Novo Nordisk Investigational Site | Boston | Massachusetts | 02144 | United States |
| Novo Nordisk Investigational Site | Boston | Massachusetts | 02215 | United States |
| Novo Nordisk Investigational Site | Detroit | Michigan | 48201 | United States |
| Novo Nordisk Investigational Site | Golden Valley | Minnesota | 55422 | United States |
| Novo Nordisk Investigational Site | Blackwater | Mississippi | 39216 | United States |
| Novo Nordisk Investigational Site | Kansas City | Missouri | 64111 | United States |
| Novo Nordisk Investigational Site | St Louis | Missouri | 63110-1010 | United States |
| Novo Nordisk Investigational Site | St Louis | Missouri | 63110 | United States |
| Novo Nordisk Investigational Site | Las Vegas | Nevada | 89109 | United States |
| Novo Nordisk Investigational Site | Lebanon | New Hampshire | 03756-0001 | United States |
| Novo Nordisk Investigational Site | Cherry Hill | New Jersey | 08034 | United States |
| Novo Nordisk Investigational Site | Hackensack | New Jersey | 07465 | United States |
| Novo Nordisk Investigational Site | Ridgewood | New Jersey | 07450 | United States |
| Novo Nordisk Investigational Site | Buffalo | New York | 14215 | United States |
| Novo Nordisk Investigational Site | New York | New York | 10032 | United States |
| Novo Nordisk Investigational Site | Stony Brook | New York | 11794-8121 | United States |
| Novo Nordisk Investigational Site | Chapel Hill | North Carolina | 27599-7025 | United States |
| Novo Nordisk Investigational Site | Charlotte | North Carolina | 28232-2861 | United States |
| Novo Nordisk Investigational Site | Durham | North Carolina | 27705 | United States |
| Novo Nordisk Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Novo Nordisk Investigational Site | Cincinnati | Ohio | 45267 | United States |
| Novo Nordisk Investigational Site | Cleveland | Ohio | 44195 | United States |
| Novo Nordisk Investigational Site | Portland | Oregon | 97225 | United States |
| Novo Nordisk Investigational Site | Portland | Oregon | 97239 | United States |
| Novo Nordisk Investigational Site | Allentown | Pennsylvania | 18103-6208 | United States |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | 15212-4746 | United States |
| Novo Nordisk Investigational Site | Pittsburgh | Pennsylvania | 15213-2546 | United States |
| Novo Nordisk Investigational Site | Charleston | South Carolina | 29425 | United States |
| Novo Nordisk Investigational Site | Chattanooga | Tennessee | 37403 | United States |
| Novo Nordisk Investigational Site | Hashville | Tennessee | 37232 | United States |
| Novo Nordisk Investigational Site | Memphis | Tennessee | 38163 | United States |
| Novo Nordisk Investigational Site | Nashville | Tennessee | 37205 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75390-8897 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77030 | United States |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78229 | United States |
| Novo Nordisk Investigational Site | Burlington | Vermont | 05401 | United States |
| Novo Nordisk Investigational Site | Charlottesville | Virginia | 22908 | United States |
| Novo Nordisk Investigational Site | Seattle | Washington | 98102 | United States |
| Novo Nordisk Investigational Site | Madison | Wisconsin | 53792-3236 | United States |
| Novo Nordisk Investigational Site | Parkville | Victoria | 3052 | Australia |
| Novo Nordisk Investigational Site | Camperdown | 2050 | Australia |
| Novo Nordisk Investigational Site | Gosford | 2250 | Australia |
| Novo Nordisk Investigational Site | Heidelberg Heights | 3081 | Australia |
| Novo Nordisk Investigational Site | Graz | 8036 | Austria |
| Novo Nordisk Investigational Site | Innsbruck | 6020 | Austria |
| Novo Nordisk Investigational Site | Antwerp | 2020 | Belgium |
| Novo Nordisk Investigational Site | Bruges | 8000 | Belgium |
| Novo Nordisk Investigational Site | Brussels | 1070 | Belgium |
| Novo Nordisk Investigational Site | Brussels | 1200 | Belgium |
| Novo Nordisk Investigational Site | Sao Cristóvao | 20941-150 | Brazil |
| Novo Nordisk Investigational Site | Vila Clementino | 04039-032 | Brazil |
| Novo Nordisk Investigational Site | Edmonton | Alberta | T6G 2B7 | Canada |
| Novo Nordisk Investigational Site | Halifax | Nova Scotia | B3H 3A7 | Canada |
| Novo Nordisk Investigational Site | Calgary | T2N 2T9 | Canada |
| Novo Nordisk Investigational Site | Greenfield Park | J4V 2H1 | Canada |
| Novo Nordisk Investigational Site | London | N6A 5A5 | Canada |
| Novo Nordisk Investigational Site | Mississauga | L5B 1B8 | Canada |
| Novo Nordisk Investigational Site | Montreal | H2L 4M1 | Canada |
| Novo Nordisk Investigational Site | Montreal | H3A 2B4 | Canada |
| Novo Nordisk Investigational Site | Ottawa | KIH 8L6 | Canada |
| Novo Nordisk Investigational Site | Québec | G1J 1Z4 | Canada |
| Novo Nordisk Investigational Site | Saint John | E2L 4L2 | Canada |
| Novo Nordisk Investigational Site | Saskatoon | S7N 0W8 | Canada |
| Novo Nordisk Investigational Site | Thunder Bay | P7B 6V4 | Canada |
| Novo Nordisk Investigational Site | Toronto | M4N 3M5 | Canada |
| Novo Nordisk Investigational Site | Vancouver | V5Z 3J5 | Canada |
| Novo Nordisk Investigational Site | Beijing | Beijing Municipality | 100050 | China |
| Novo Nordisk Investigational Site | Shanghai | Shanghai Municipality | 200001 | China |
| Novo Nordisk Investigational Site | Shanghai | Shanghai Municipality | 200040 | China |
| Novo Nordisk Investigational Site | Zagreb | 10000 | Croatia |
| Novo Nordisk Investigational Site | Aalborg | 9100 | Denmark |
| Novo Nordisk Investigational Site | Aarhus | 8000 | Denmark |
| Novo Nordisk Investigational Site | Copenhagen | Denmark |
| Novo Nordisk Investigational Site | Glostrup Municipality | 2600 | Denmark |
| Novo Nordisk Investigational Site | Helsinki | FI-00029 | Finland |
| Novo Nordisk Investigational Site | Kuopio | FI-70211 | Finland |
| Novo Nordisk Investigational Site | Seinäjoki | FI-60220 | Finland |
| Novo Nordisk Investigational Site | Turku | FI-20521 | Finland |
| Novo Nordisk Investigational Site | Bordeaux | 33076 | France |
| Novo Nordisk Investigational Site | Paris | 75010 | France |
| Novo Nordisk Investigational Site | Paris | 75013 | France |
| Novo Nordisk Investigational Site | Paris | 75877 | France |
| Novo Nordisk Investigational Site | Toulouse | 31054 | France |
| Novo Nordisk Investigational Site | Berlin | 13353 | Germany |
| Novo Nordisk Investigational Site | Dresden | 01307 | Germany |
| Novo Nordisk Investigational Site | Essen | 45147 | Germany |
| Novo Nordisk Investigational Site | Heidelberg | 69120 | Germany |
| Novo Nordisk Investigational Site | Leipzig | 04103 | Germany |
| Novo Nordisk Investigational Site | Mannheim | 68167 | Germany |
| Novo Nordisk Investigational Site | Minden | 32427 | Germany |
| Novo Nordisk Investigational Site | München | 81545 | Germany |
| Novo Nordisk Investigational Site | Münster | 48149 | Germany |
| Novo Nordisk Investigational Site | Hong Kong | Hong Kong |
| Novo Nordisk Investigational Site | Tel Aviv | 64239 | Israel |
| Novo Nordisk Investigational Site | Tel Litwinsky | 52621 | Israel |
| Novo Nordisk Investigational Site | Florence | 50134 | Italy |
| Novo Nordisk Investigational Site | Pavia | 27100 | Italy |
| Novo Nordisk Investigational Site | Perugia | 06156 | Italy |
| Novo Nordisk Investigational Site | Roma | 00185 | Italy |
| Novo Nordisk Investigational Site | Amsterdam | 1066 EC | Netherlands |
| Novo Nordisk Investigational Site | Amsterdam | 1105 AZ | Netherlands |
| Novo Nordisk Investigational Site | Eindhoven | 5623 EJ | Netherlands |
| Novo Nordisk Investigational Site | Heerlen | 6419 PC | Netherlands |
| Novo Nordisk Investigational Site | Rotterdam | 3015 GD | Netherlands |
| Novo Nordisk Investigational Site | Utrecht | 3584 CX | Netherlands |
| Novo Nordisk Investigational Site | Bergen | 5021 | Norway |
| Novo Nordisk Investigational Site | Kristiansand | 4604 | Norway |
| Novo Nordisk Investigational Site | Nordbyhagen | 1474 | Norway |
| Novo Nordisk Investigational Site | Stavanger | NO-4011 | Norway |
| Novo Nordisk Investigational Site | Trondheim | NO-7030 | Norway |
| Novo Nordisk Investigational Site | Singapore | 119074 | Singapore |
| Novo Nordisk Investigational Site | Singapore | 308443 | Singapore |
| Novo Nordisk Investigational Site | Badalona | 08916 | Spain |
| Novo Nordisk Investigational Site | Barcelona | 08035 | Spain |
| Novo Nordisk Investigational Site | Barcelona | 08036 | Spain |
| Novo Nordisk Investigational Site | Girona | 17007 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28040 | Spain |
| Novo Nordisk Investigational Site | Linköping | 581 85 | Sweden |
| Novo Nordisk Investigational Site | Malmö | 214 28 | Sweden |
| Novo Nordisk Investigational Site | Stockholm | 118 83 | Sweden |
| Novo Nordisk Investigational Site | Stockholm | 141 86 | Sweden |
| Novo Nordisk Investigational Site | Stockholm | 171 76 | Sweden |
| Novo Nordisk Investigational Site | Umeå | 901 85 | Sweden |
| Novo Nordisk Investigational Site | Lausanne | 1011 | Switzerland |
| Novo Nordisk Investigational Site | Taipei | 100 | Taiwan |
| Novo Nordisk Investigational Site | Taipei | 114 | Taiwan |
| Novo Nordisk Investigational Site | Taoyuan | 333 | Taiwan |
| Novo Nordisk Investigational Site | Bangkok | 10330 | Thailand |
| Novo Nordisk Investigational Site | Bangkok | 10400 | Thailand |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D005167 | Factor VII |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
Not provided
Not provided