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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1212-4050 | Other Identifier | World Health Organization (WHO) | |
| EUPAS25696 | Registry Identifier | EU PAS Register |
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The purpose of this study is to collect data on adverse events from third party registries that include information about adverse events from patients with haemophilia B treated with nonacog beta pegol. The third party registries include PedNet Haemophilia Registry (PedNet) and the European Haemophilia Safety Surveillance System (EUHASS). Data from national and international registries in countries where nonacog beta pegol has been approved and marketed could be included in the data collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with haemophilia B | Patients with haemophilia B treated with nonacog beta pegol who report adverse events to the PedNet and EUHASS, and possibly other national or international registries. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nonacog beta pegol | Drug | Treatment with commercially available nonacog beta pegol according to routine clinical practice at the discretion of the treating physician. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Drug Reactions (ADRs) reported to the registries with suspected relation to nonacog beta pegol in patients with haemophilia B | Number of events (renal, hepatic, neurodevelopmental, neurocognitive, neurologic or psychiatric events) | From start of data collection (week 0) to end of data collection (after 9 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Other ADRs reported to the registries during the study period with suspected relation to nonacog beta pegol in patients with haemophilia B | Number of events (de novo FIX inhibitors more than or equal to 0.6 Bethesda units); anaphylaxis and other allergic reactions; thromboembolic events) | From start of data collection (week 0) to end of data collection (after 9 years) |
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Inclusion Criteria:
- Participation in the PedNet Registry and/or the European Haemophilia Safety Surveillance System (EUHASS), or other national and international registries
Exclusion Criteria:
- Not applicable as this is a study collecting third-party data from registries
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Patients with haemophilia B
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PedNet Haemophilia Registry | Baarn | Netherlands | ||||
| European Haemophilia Safety Surveillance Registry |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D002836 | Hemophilia B |
| 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 |
|---|---|
| C000592276 | nonacog beta pegol |
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| Sheffield |
| United Kingdom |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |