Cirrhosis Clinical Trial
Official title:
Effectiveness and Safety of Use of NovoSeven® in the Treatment of Active Variceal Bleeding in Patients With Advanced Cirrhosis
| Verified date | January 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This trial is conducted in Asia and Europe. The trial is planned to investigate the effectiveness and safety of NovoSeven® in patients with advanced cirrhosis and active variceal bleeding.
| Status | Completed |
| Enrollment | 265 |
| Est. completion date | August 2006 |
| Est. primary completion date | August 2006 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 79 Years |
| Eligibility |
Inclusion Criteria: - Variceal bleeding |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Novo Nordisk Investigational Site | Wien | |
| Czech Republic | Novo Nordisk Investigational Site | Olomouc | |
| Czech Republic | Novo Nordisk Investigational Site | Prague 4 | |
| Czech Republic | Novo Nordisk Investigational Site | Praha 2 | |
| Denmark | Novo Nordisk Investigational Site | Århus | |
| Finland | Novo Nordisk Investigational Site | Helsinki | |
| France | Novo Nordisk Investigational Site | ANGERS cedex 09 | |
| France | Novo Nordisk Investigational Site | Caen | |
| France | Novo Nordisk Investigational Site | Clichy | |
| France | Novo Nordisk Investigational Site | GRENOBLE cedex | |
| France | Novo Nordisk Investigational Site | Lille | |
| France | Novo Nordisk Investigational Site | LIMOGES cedex | |
| France | Novo Nordisk Investigational Site | MARSEILLE cedex 05 | |
| France | Novo Nordisk Investigational Site | NANTES cedex 1 | |
| France | Novo Nordisk Investigational Site | NICE cedex 3 | |
| France | Novo Nordisk Investigational Site | Paris | |
| France | Novo Nordisk Investigational Site | Paris | |
| France | Novo Nordisk Investigational Site | TOULOUSE cedex | |
| France | Novo Nordisk Investigational Site | Villejuif | |
| Germany | Novo Nordisk Investigational Site | Berlin | |
| Germany | Novo Nordisk Investigational Site | Heidelberg | |
| Germany | Novo Nordisk Investigational Site | Leipzig | |
| Germany | Novo Nordisk Investigational Site | München | |
| Germany | Novo Nordisk Investigational Site | Münster | |
| Germany | Novo Nordisk Investigational Site | Ulm | |
| Hong Kong | Novo Nordisk Investigational Site | Shatin | |
| Italy | Novo Nordisk Investigational Site | Milano | |
| Italy | Novo Nordisk Investigational Site | Napoli | |
| Italy | Novo Nordisk Investigational Site | Palermo | |
| Poland | Novo Nordisk Investigational Site | Katowice | |
| Poland | Novo Nordisk Investigational Site | Krakow | |
| Poland | Novo Nordisk Investigational Site | Warszawa | |
| Spain | Novo Nordisk Investigational Site | Badalona | |
| Spain | Novo Nordisk Investigational Site | Barcelona | |
| Spain | Novo Nordisk Investigational Site | Barcelona | |
| Spain | Novo Nordisk Investigational Site | Barcelona | |
| Spain | Novo Nordisk Investigational Site | Córdoba | |
| Spain | Novo Nordisk Investigational Site | Madrid | |
| Spain | Novo Nordisk Investigational Site | Madrid | |
| Spain | Novo Nordisk Investigational Site | Majadahonda | |
| Taiwan | Novo Nordisk Investigational Site | Taipei | |
| United Kingdom | Novo Nordisk Investigational Site | Leeds | |
| United Kingdom | Novo Nordisk Investigational Site | London | |
| United Kingdom | Novo Nordisk Investigational Site | Oxford |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Austria, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Italy, Poland, Spain, Taiwan, United Kingdom,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatment failure | Within 5 days after first trial product administration | ||
| Secondary | Mortality | |||
| Secondary | Rebleeding | |||
| Secondary | Control of acute bleeding |
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