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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1235-5939 | Other Identifier | World Health Organization (WHO) |
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This non-interventional study concerns a safety data collection based on adverse event data from a third-party registry (European Haemophilia Safety Surveillance System, EUHASS) that includes information about adverse events from patients with haemophilia A treated with turoctocog alfa pegol. There is no extra burden to the patients by participating in this registry-based data collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haemophilia A patients | All patients with haemophilia A treated with turoctocog alfa pegol and reporting adverse events to EUHASS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Turoctocog alfa pegol | Drug | Patients will be treated with commercially available turoctocog alfa pegol according to routine clinical practice at the discretion of the treating physician. A decision to initiate treatment with commercially available turoctocog alfa pegol has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in the registry in scope. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) reported to the registry with suspected relation to turoctocog alfa pegol, Adverse Drug Reactions (ADRs), in patients with haemophilia A for renal, hepatic and neurological events. | Count | From start to end of data collection (December 2019 to January 2025) |
| Measure | Description | Time Frame |
|---|---|---|
| Other AEs reported to the registry during the study period with suspected relation to turoctocog alfa pegol in patients with haemophilia A | Count. Includes ADRs of special interest (de novo FVIII inhibitors equal to or above 0.6 Bethesda Units (BU)); anaphylaxis and other allergic reactions; thromboembolic events). | From start to end of data collection (December 2019 to January 2025) |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with haemophilia A treated with turoctocog alfa pegol and reporting adverse events to EUHASS.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor & Disclosure (2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Søborg | 2860 | Denmark |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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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| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |