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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-000729-40 | EudraCT Number |
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This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rFXIII | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| catridecacog | Drug | Single doses of rFXIII administered intravenously (i.v.) to eight subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | From dosing up to 5-7 weeks ± 3 days after trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and magnitude of laboratory abnormalities following administration of rFXIII | From dosing up to 5-7 weeks ± 3 days after trial product administration | |
| Incidence of antibodies to FXIII-A subunit | From dosing up to 5-7 weeks ± 3 days after trial product administration |
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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 | Tucson | Arizona | 85714 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19806264 | Result | Levy JH, Gill R, Nussmeier NA, Olsen PS, Andersen HF, Booth FV, Jespersen CM. Repletion of factor XIII following cardiopulmonary bypass using a recombinant A-subunit homodimer. A preliminary report. Thromb Haemost. 2009 Oct;102(4):765-71. doi: 10.1160/TH08-12-0826. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo | Drug | Single doses of placebo administered intravenously (i.v.) to two subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg). |
|
| Incidence of anti-yeast antibodies | From dosing up to 5-7 weeks ± 3 days after trial product administration |
| San Francisco |
| California |
| 94143 |
| United States |
| Novo Nordisk Investigational Site | Denver | Colorado | 80262 | United States |
| Novo Nordisk Investigational Site | Indianapolis | Indiana | 46290 | United States |
| Novo Nordisk Investigational Site | Camden | New Jersey | 08103 | United States |
| Novo Nordisk Investigational Site | New York | New York | 10032 | United States |
| Novo Nordisk Investigational Site | The Bronx | New York | 10461 | United States |
| Novo Nordisk Investigational Site | The Bronx | New York | 10467 | United States |
| Novo Nordisk Investigational Site | Cleveland | Ohio | 44195 | United States |
| Novo Nordisk Investigational Site | Portland | Oregon | 97207 | United States |
| Novo Nordisk Investigational Site | Portland | Oregon | 97239-3098 | United States |
| Novo Nordisk Investigational Site | Allentown | Pennsylvania | 18103 | United States |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19107-5092 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77030 | United States |
| Novo Nordisk Investigational Site | Richmond | Virginia | 23298 | United States |
| Novo Nordisk Investigational Site | Toronto | M5G-2C4 | Canada |
| Novo Nordisk Investigational Site | København Ø | 2100 | Denmark |
| Novo Nordisk Investigational Site | Hamburg | 20246 | Germany |
| Novo Nordisk Investigational Site | Lahr | 77933 | Germany |
| Novo Nordisk Investigational Site | Mainz | 55131 | Germany |
| Novo Nordisk Investigational Site | Cambridge | CB3 8RE | United Kingdom |
| Novo Nordisk Investigational Site | London | W1G 8PH | United Kingdom |
| Novo Nordisk Investigational Site | Middlesbrough | TS4 3BW | United Kingdom |
| Novo Nordisk Investigational Site | Southampton | SO16 6YD | United Kingdom |