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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020465-24 | EudraCT Number | ||
| U1111-1116-2356 | Other Identifier | WHO |
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This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the safety, pharmacokinetics (how the trial drug is distributed in the body) and pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021 administered intravenously and subcutaneously to healthy male subjects and subjects with haemophilia A or B
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC 0172-0000-2021 | Drug | Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse Events (AEs), including Serious Adverse Events (SAEs) | from trial product administration until 43 days after trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve | from 43 days after trial product administration until 53 days after trial product administration | |
| Adverse Events (AEs), including Serious Adverse Events (SAEs) | from 43 days after trial product administration until 53 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 | Vienna | 1090 | Austria | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25641556 | Result | Chowdary P, Lethagen S, Friedrich U, Brand B, Hay C, Abdul Karim F, Klamroth R, Knoebl P, Laffan M, Mahlangu J, Miesbach W, Dalsgaard Nielsen J, Martin-Salces M, Angchaisuksiri P. Safety and pharmacokinetics of anti-TFPI antibody (concizumab) in healthy volunteers and patients with hemophilia: a randomized first human dose trial. J Thromb Haemost. 2015 May;13(5):743-54. doi: 10.1111/jth.12864. Epub 2015 Apr 6. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| NNC 0172-0000-2021 | Drug | Single dose injected s.c. (under the skin). Each treatment dose is assessed for safety before escalating to next dose. |
|
| placebo | Drug | Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose. |
|
| Copenhagen |
| 2100 |
| Denmark |
| Novo Nordisk Investigational Site | Berlin | 10249 | Germany |
| Novo Nordisk Investigational Site | Frankfurt/M. | 60590 | Germany |
| Novo Nordisk Investigational Site | Milan | 20124 | Italy |
| Novo Nordisk Investigational Site | Kuala Lumpur | 50400 | Malaysia |
| Novo Nordisk Investigational Site | Polokwane | Limpopo | 0699 | South Africa |
| Novo Nordisk Investigational Site | Madrid | 28046 | Spain |
| Novo Nordisk Investigational Site | Malmö | 205 02 | Sweden |
| Novo Nordisk Investigational Site | Zurich | 8091 | Switzerland |
| Novo Nordisk Investigational Site | Bangkok | 10400 | Thailand |
| Novo Nordisk Investigational Site | Harrow | HA1 3UJ | United Kingdom |
| Novo Nordisk Investigational Site | London | NW3 2QG | United Kingdom |
| Novo Nordisk Investigational Site | London | SE1 7EH | United Kingdom |
| Novo Nordisk Investigational Site | London | W12 0NN | United Kingdom |
| Novo Nordisk Investigational Site | Manchester | M13 9WL | United Kingdom |
| 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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