Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005757-32 | EudraCT Number | ||
| U1111-1126-0327 | Other Identifier | WHO |
Not provided
Not provided
See detailed description
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in Europe. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia.
The present phase 1 trial has been terminated due to the need for changes in the trial design requiring a new re-designed multiple dosing phase 1 trial. Initiation of this new trial awaits additional non-clinical data.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose (healthy subjects) | Experimental |
| |
| Medium dose (subjects with haemophilia) | Experimental |
| |
| High dose (subjects with haemophilia) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC172-2021 | Drug | Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks. Escalation to next dose level is based on a safety evaluation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events (AEs) | From first trial drug administration through trial day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Local tolerability | After the last s.c. dose administration (trial day 15) | |
| Thrombocyte count | After the last s.c. dose administration (trial day 15) | |
| Trough level (Ctrough) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|
| Result | Waters EK, Sigh J et al.: Trombin generation is increased in plasma from healthy males who have received concizumab, an antibody against tissue factor pathway inhibitor (ExplorerTM 2); Journal of Thrombosis and Haemostasis, Abstracts 2015; 13(Suppl. S2): 1-997(AS019) |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Prior to the last s.c. dose administration (trial day 15) |
| Lyon |
| 69003 |
| France |
| Novo Nordisk Investigational Site | Montpellier | 34295 | France |
| Novo Nordisk Investigational Site | Berlin | 10249 | Germany |
| Novo Nordisk Investigational Site | Madrid | 28046 | Spain |
| Novo Nordisk Investigational Site | Harrow | HA1 3UJ | United Kingdom |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| 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 |
Not provided
Not provided