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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021286-67 | EudraCT Number | ||
| U1111-1118-0208 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of this trial is to investigate the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of NNC 0128-0000-2011 compared to NNC 0128-0000-2021 when given for the first time to healthy human subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC 0128-0000-2011 | Drug | Administered as one single i.v. (intravenous) injection, 100 mcg/kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events (AEs) | from first trial product administration until maximally 10 weeks after last trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralising antibodies against FVII and/or N7-GP | from first trial product administration until maximally 10 weeks after last 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 |
|---|---|---|---|---|---|---|
| Manchester | M15 6SH | United Kingdom |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| NNC 0128-0000-2021 |
| Drug |
Administered as one single i.v. (intravenous) injection, 100 mcg/kg |
|
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
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