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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021127-28 | EudraCT Number | ||
| U1111-1118-6995 | Other Identifier | WHO | |
| JapicCTI-111455 | Registry Identifier | JAPIC |
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This trial is conducted in Europe and Japan. The aim of this trial is to assess the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of single doses of NNC128-0000-2011, when administered i.v. (intravenously) to haemophilia patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mcg/kg | Experimental |
| |
| 200 mcg/kg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC 0128-0000-2011 | Drug | Single dose of 100 mcg/kg NNC128-0000-2011 administered i.v. (intravenously) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events (AEs) | from first trial product administration until 12 weeks after last trial product administration | |
| Frequency of serious adverse events (SAEs) | from first trial product administration until 12 weeks after last trial product administration | |
| Frequency of MESIs (Medical Event of Special Interest) | from first trial product administration until 12 weeks after last trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralising antibodies against FVIIa and/or N7-GP | from first trial product administration until 12 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 |
|---|---|---|---|---|---|---|
| Berlin | 10249 | Germany | ||||
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| NNC 0128-0000-2011 | Drug | Single dose of 200 mcg/kg NNC128-0000-2011 administered i.v. (intravenously) |
|
| Kitakyushu |
| 807-8555 |
| Japan |
| Madrid | 28046 | Spain |
| 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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