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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1144-8212 | Other Identifier | WHO |
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This study is conducted in Asia. The aim of this study is to evaluate the safety and efficacy of NovoEight® (recombinant factor VIII) in patients with haemophilia A in Japan in the setting of routine clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NovoEight® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| turoctocog alfa | Drug | No treatment given. Patients will be treated with commercially available NovoEight®. Patients will be treated according to local clinical practice at the direction of the physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events (AEs) | Week 0- 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Reactions (ARs) | Week 0- 104 | |
| Frequency of Serious Adverse Events (SAEs) | Week 0- 104 | |
| Frequency of Serious Adverse Reactions (SARs) |
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Inclusion Criteria:
Exclusion Criteria:
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NovoEight® in prevention, treatment of bleeds and prevention of bleeds during and after surgery in previously treated patients (PTPs) and previously untreated patients (PUPs) with haemophilia A in routine clinical setting in Japan.
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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 | Suginami-ku, Tokyo | 1670035 | Japan | |||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C577506 | recombinant factor VIII N8 |
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| Week 0- 104 |
| Haemostatic effect of NovoEight® in the treatment of bleeds according to a predefined four point scale: Excellent, Good, Moderate, or None for patients with preventive regimen and on-demand treatment regimen, respectively | Week 0- 104 |
| Haemostatic effect of NovoEight® during surgical procedures assessed by evaluation according to a predefined four point scale: Excellent, Good, Moderate, or None | Week 0- 104 |
| Annualised bleeding rate for patients using NovoEight® for preventive regimen | Week 0- 104 |
| Total consumption of NovoEight® per patient (prevention, treatment of bleeds and surgery) per year (IU/kg BW/year/patient) | Week 0- 104 |
| Consumption of NovoEight® per bleed (IU/kg BW/bleeding episode) | Week 0- 104 |
| Consumption of NovoEight® per month (IU/kg BW/month) for prevention | Week 0- 104 |
| Consumption of NovoEight® (IU/kg BW) from the day of surgery until the day of return to preventive regimen or on-demand treatment regimen | Week 0- 104 |
| Tokyo |
| 167-0035 |
| Japan |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |