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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1165-8657 | Other Identifier | World Health Organization (WHO) | |
| EUPAS26592 | Registry Identifier | EU PAS Register |
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This study will collect information on side effects and how well Refixia/REBINYN works during long-term treatment (prophylaxis) in males with haemophilia B. While taking part in this study, participants will receive the same treatment as given to them by their study doctor. All visits at the clinic are done in the same way as the participants are used to. During visits at the clinic, participants might be asked for some relevant tests if considered useful by their study doctor. During the visits, the participants study doctor might ask if the participants had any side effects since their last study visit. The participants will be asked to note down the number of bleeds and the treatment of their bleeds as well as their regular prophylaxis. During the visits to the clinic, the participants will be asked to answer some questionnaires about their quality of life and their ability to be physically active. The participant's participation in the study will last for 4-9 years, depending on when they join the study. Participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with haemophilia B | Patients with haemophilia B without current inhibitors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nonacog beta pegol | Drug | Participants are treated with commercially available nonacog beta pegol (N9-GP) according to local clinical practice at the discretion of the treating physician |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Drug Reactions (ADRs) (FIX inhibitors, allergic reactions, and thromboembolic events) | Count of events | From start of study period (week 0) to end of study period (up to 9 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events (SAEs) | Count of events | From start of study period (week 0) to up to 9 years |
| Number of bleeding episodes during long-term routine use of N9-GP (prophylaxis) as assessed by annualised bleeding rate (ABR) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with haemophilia B
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Reporting Anchor and Disclosure (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKH - Klin. Abt. f. Haematologie u. Haemostaseologie | Vienna | 1090 | Austria | |||
| Cliniques universitaires Saint-Luc - Service Hématologie |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Count of episodes
| From start of study period (week 0) to up to 9 years |
| Number of treatment requiring bleeding episodes during long-term routine use of N9-GP (prophylaxis) as assessed by annualised bleeding rate (ABR) | Number of episodes | From start of study period (week 0) to up to 9 years |
| Haemostatic effect of N9-GP when used for treatment of bleeding episodes | Count of bleeding episodes. Haemostatic effect is assessed as success/failure based on a four-point scale for haemostatic response (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure | From start of study period (week 0) to up to 9 years |
| Haemostatic response of N9-GP when used in perioperative management | Count of bleeding episodes. Haemostatic response is assessed as success/failure based on a four-point scale for haemostatic response (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure | From start of study period (week 0) to end of study period (up to 9 years) |
| Brussels |
| 1200 |
| Belgium |
| UZ Antwerpen - UZA - Kinderhemato-Oncologie | Edegem | 2650 | Belgium |
| UZ Leuven - Hart en Vaatziekten | Leuven | 3000 | Belgium |
| University of Calgary Cumming School of Medicine | Calgary | Alberta | T2N 2T9 | Canada |
| Univ of Alberta Hospital Res | Edmonton | Alberta | T6G 2V2 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Health Science Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Hamilton Health Sciences Corp, Ontario | Hamilton | Ontario | L8N 3Z5 | Canada |
| Hamltn Hth Sci/McMstr Child Hosp | Hamilton | Ontario | L8N 3Z5 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| KBC Zagreb_Hematology | Zagreb | 10 000 | Croatia |
| Fakultní nemocnice Brno | Brno | 625 00 | Czechia |
| FN Brno odd. hematologie | Brno | 625 00 | Czechia |
| Fakultni nemocnice Plzen - Lochotin | Pilsen | 304 60 | Czechia |
| Skejby Blodsygdomme, blødercentret | Aarhus N | 8200 | Denmark |
| Coagulation Disorder Unit | Helsinki | 00290 | Finland |
| Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain | Berlin | 10249 | Germany |
| Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie | Bonn | 53127 | Germany |
| "Laiko" General Hospital of Athens | Athens | 11527 | Greece |
| "Laiko" General Hospital of Athens | Athens | GR-11527 | Greece |
| Aghia Sophia Childrens' Hospital | Athens | GR-11527 | Greece |
| Klinisk forskningspost | Oslo | 0372 | Norway |
| ULS De São José, E.P.E - Hospital São José_Serviço de Imunohemoterapia | Lisbon | 1150-199 | Portugal |
| ULS De São José, E.P.E.- Hospital D. Estefânia | Lisbon | 1169-045 | Portugal |
| Universitätsspital Zürich - Klinik für Medizinische Onkologie und Hämatologie | Zurich | 8091 | Switzerland |
| Aberdeen Royal Infirmary - Haematology | Aberdeen | AB25 2ZN | United Kingdom |
| University Hospital of Wales - Haemophilia | Cardiff | CF14 4XW | United Kingdom |
| Royal Manchester Children's Hospital | Manchester | M13 9WL | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | S10 2JF | United Kingdom |
| ID | Term |
|---|---|
| D002836 | Hemophilia B |
| 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 |
| D040181 | Genetic Diseases, X-Linked |
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| ID | Term |
|---|---|
| C000592276 | nonacog beta pegol |
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