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This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor VII in patients having undergone allogeneic or autologous stem cell transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Low dose | Experimental |
| |
| Medium dose | Experimental |
| |
| High dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard therapy | Procedure | Standard treatment of bleeding |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect on bleeding, defined as change in bleeding score |
| Measure | Description | Time Frame |
|---|---|---|
| Transfusion requirements | ||
| Bleeding evaluation | ||
| 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 | Chapel Hill | North Carolina | 27599-7035 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16102099 | Result | Pihusch M, Bacigalupo A, Szer J, von Depka Prondzinski M, Gaspar-Blaudschun B, Hyveled L, Brenner B; F7BMT-1360 Trial Investigators. Recombinant activated factor VII in treatment of bleeding complications following hematopoietic stem cell transplantation. J Thromb Haemost. 2005 Sep;3(9):1935-44. doi: 10.1111/j.1538-7836.2005.01523.x. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| activated recombinant human factor VII | Drug | Two days repeated treatment regimen - low dose administered i.v. (into the vein) |
|
| activated recombinant human factor VII | Drug | Two days repeated treatment regimen - medium dose administered i.v. (into the vein) |
|
| activated recombinant human factor VII | Drug | Two days repeated treatment regimen - high dose administered i.v. (into the vein) |
|
| placebo | Drug | Placebo |
|
| Herston |
| 4029 |
| Australia |
| Novo Nordisk Investigational Site | Parkville | 3050 | Australia |
| Novo Nordisk Investigational Site | Westmead | 2145 | Australia |
| Novo Nordisk Investigational Site | Vienna | A -1090 | Austria |
| Novo Nordisk Investigational Site | Copenhagen | 2100 | Denmark |
| Novo Nordisk Investigational Site | Helsinki | 00029 | Finland |
| Novo Nordisk Investigational Site | Besançon | 25030 | France |
| Novo Nordisk Investigational Site | Lille | 59037 | France |
| Novo Nordisk Investigational Site | Tours | 37044 | France |
| Novo Nordisk Investigational Site | Cologne | 50924 | Germany |
| Novo Nordisk Investigational Site | Dresden | 01307 | Germany |
| Novo Nordisk Investigational Site | Hamburg | 20246 | Germany |
| Novo Nordisk Investigational Site | Hanover | 30625 | Germany |
| Novo Nordisk Investigational Site | Idar-Oberstein | 55743 | Germany |
| Novo Nordisk Investigational Site | München | 81377 | Germany |
| Novo Nordisk Investigational Site | Regensburg | 93042 | Germany |
| Novo Nordisk Investigational Site | Tübingen | 72076 | Germany |
| Novo Nordisk Investigational Site | Wiesbaden | 65191 | Germany |
| Novo Nordisk Investigational Site | Haifa | 31096 | Israel |
| Novo Nordisk Investigational Site | Jerusalem | 91120 | Israel |
| Novo Nordisk Investigational Site | Florence | 50134 | Italy |
| Novo Nordisk Investigational Site | Genova | 16132 | Italy |
| Novo Nordisk Investigational Site | Pesaro | 61100 | Italy |
| Novo Nordisk Investigational Site | Rome | 00144 | Italy |
| Novo Nordisk Investigational Site | Udine | 33100 | Italy |
| Novo Nordisk Investigational Site | Gdansk | 80-952 | Poland |
| Novo Nordisk Investigational Site | Katowice | 40-029 | Poland |
| Novo Nordisk Investigational Site | Poznan | 60-569 | Poland |
| Novo Nordisk Investigational Site | Warsaw | 00-909 | Poland |
| Novo Nordisk Investigational Site | Warsaw | 02-097 | Poland |
| Novo Nordisk Investigational Site | Wroclaw | 50-345 | Poland |
| Novo Nordisk Investigational Site | Wroclaw | 53-439 | Poland |
| Novo Nordisk Investigational Site | Singapore | 169608 | Singapore |
| Novo Nordisk Investigational Site | Barcelona | 08036 | Spain |
| Novo Nordisk Investigational Site | Santander | 39008 | Spain |
| Novo Nordisk Investigational Site | Valencia | 46026 | Spain |
| Novo Nordisk Investigational Site | Gothenburg | 413 45 | Sweden |
| Novo Nordisk Investigational Site | Stockholm | 141 86 | Sweden |
| Novo Nordisk Investigational Site | Uppsala | 751 85 | Sweden |
| Novo Nordisk Investigational Site | Basel | 4031 | Switzerland |
| Novo Nordisk Investigational Site | Zurich | 8091 | Switzerland |
| Novo Nordisk Investigational Site | Bangkok | 10330 | Thailand |
| Novo Nordisk Investigational Site | Bangkok | Thailand |
| Novo Nordisk Investigational Site | London | W12 OHS | United Kingdom |
| Novo Nordisk Investigational Site | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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