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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018520-68 | EudraCT Number | ||
| U1111-1116-2043 | Other Identifier | WHO | |
| JapicCTI-101293 | Other Identifier | JAPIC |
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This trial is conducted globally. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of NNC 0129-0000-1003 in previously treated subjects with severe haemophilia A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| turoctocog alfa pegol | Drug | Single dose (low) administered intravenously (into the vein) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events (AEs) reported after administration of trial product | up to four weeks after trial product administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC), total clearance (CL), terminal half-life (T½), incremental recovery (first sample) | from 0 to 168 hours after trial product administration | |
| Safety assessment including physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory assessments |
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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 | Iowa City | Iowa | 52242 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23398640 | Result | Tiede A, Brand B, Fischer R, Kavakli K, Lentz SR, Matsushita T, Rea C, Knobe K, Viuff D. Enhancing the pharmacokinetic properties of recombinant factor VIII: first-in-human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A. J Thromb Haemost. 2013 Apr;11(4):670-8. doi: 10.1111/jth.12161. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| turoctocog alfa pegol | Drug | Single dose (medium) administered intravenously (into the vein) |
|
|
| turoctocog alfa pegol | Drug | Single dose (high) administered intravenously (into the vein) |
|
|
| up to four weeks after trial product administration |
| Lexington |
| Kentucky |
| 40536 |
| United States |
| Novo Nordisk Investigational Site | Baltimore | Maryland | 21287 | United States |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77030 | United States |
| Novo Nordisk Investigational Site | Frankfurt/M. | 60590 | Germany |
| Novo Nordisk Investigational Site | Giessen | 35392 | Germany |
| Novo Nordisk Investigational Site | Hanover | 30625 | Germany |
| Novo Nordisk Investigational Site | Florence | 50134 | Italy |
| Novo Nordisk Investigational Site | Vicenza | 36100 | Italy |
| Novo Nordisk Investigational Site | Kashihara-shi, Nara | 634 8522 | Japan |
| Novo Nordisk Investigational Site | Nagoya-shi, Aichi | 466 8560 | Japan |
| Novo Nordisk Investigational Site | Shinjuku-ku, Tokyo | 160 0023 | Japan |
| Novo Nordisk Investigational Site | Zurich | 8091 | Switzerland |
| Novo Nordisk Investigational Site | Bornova-IZMIR | 35100 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | London | NW3 2QG | United Kingdom |
| Novo Nordisk Investigational Site | London | SE1 7EH | United Kingdom |
| Novo Nordisk Investigational Site | Manchester | M13 9WL | 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 |
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