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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1117-1286 | Other Identifier | WHO | |
| JapicCTI-101346 | Other Identifier | JAPIC |
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This trial is conducted in Japan. The aim of this clinical trial is to investigate the pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog alfa (recombinant factor VIII (N8)) in Japanese subjects with haemophilia A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| recombinant factor VIII (N8) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| turoctocog alfa | Drug | Subjects will receive recombinant factor VIII (N8) at a dose of 50 +/- 5 IU/kg body weight. Intravenous administration as a single bolus injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve | Infusion, 30 minutes | |
| Incremental recovery | Infusion, 30 minutes | |
| In vivo t1/2 | Infusion, 30 minutes | |
| Total clearance (CL) | Infusion, 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal concentration | at 15 minutes | |
| Area under the curve | from time zero to last | |
| Number of adverse events |
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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 | Itabashi-ku, Tokyo | 173 8606 | Japan | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25495795 | Result | Jimenez-Yuste V, Lejniece S, Klamroth R, Suzuki T, Santagostino E, Karim FA, Saugstrup T, Moss J. The pharmacokinetics of a B-domain truncated recombinant factor VIII, turoctocog alfa (NovoEight(R)), in patients with hemophilia A. J Thromb Haemost. 2015 Mar;13(3):370-9. doi: 10.1111/jth.12816. Epub 2015 Feb 13. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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|
| from day -1 to day 3 (end of trial) |
| Kashihara-shi, Nara |
| 634 8522 |
| Japan |
| Novo Nordisk Investigational Site | Maebashi-shi, Gunma | 371-8511 | Japan |
| Novo Nordisk Investigational Site | Shinjuku-ku, Tokyo | 160 0023 | Japan |
| Novo Nordisk Investigational Site | Shizuoka-shi, Shizuoka | 4208660 | Japan |
| Novo Nordisk Investigational Site | Suginami-ku, Tokyo | 1670035 | Japan |
| 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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| ID | Term |
|---|---|
| C577506 | recombinant factor VIII N8 |
| D005169 | Factor VIII |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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