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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS36536 | Registry Identifier | EU PAS Register | |
| U1111-1235-6007 | Other Identifier | World Health Organization (WHO) |
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This study will collect information on side effects and how well Esperoct® (turoctocog alfa pegol (N8-GP)) works during long-term treatment (prophylaxis) in males with haemophilia A. Participants in this study will get the same treatment as they would normally get, if they were not participating in the study. All visits at the clinic are done in the same way as participants are used to, when visiting their doctor. During visits at the clinic participants might be asked for some relevant tests if considered useful by the study doctor. During the visits the study doctor might ask if participants had any side effects since the last study visit. Participants will be asked to note down in their own diary the number of bleeds and how these were treated, as well as their regular prophylaxis. Participation in the study will last for about 5-7 years, depending on when participants 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 |
|---|---|---|---|
| N8-GP | Patients with haemophilia A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Turoctocog alfa pegol (N8-GP) | Drug | Patients will be treated with commercially available N8-GP for prophylaxis and treatment of bleeding episodes according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available N8-GP 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 this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) reported during the study period | Count of events | From inclusion of the patient (Visit 1) until the end of study (Visit 3), duration 5-7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events (SAEs) reported during the study period | Count of events | From inclusion of the patient (Visit 1) until the end of study (Visit 3), duration 5-7 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with haemophilia A
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKH - Klin. Abt. f. Haematologie u. Haemostaseologie | Vienna | 1090 | Austria | |||
| UMHAT "Tsaritsa Yoanna-ISUL" |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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|
| Sofia |
| 1527 |
| Bulgaria |
| KBC Zagreb, Rebro, Hemofilija centar | Zagreb | 10 000 | Croatia |
| FN Brno odd. hematologie | Brno | 625 00 | Czechia |
| FN HK - IV. Interni hematologicka klinika | Hradec Králové | 500 05 | Czechia |
| North Estonia Medical Centre Foundation | Tallinn | 13419 | Estonia |
| Tartu University Hospital Haematology Clinic | Tartu | 50406 | Estonia |
| 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 |
| MH Eü. Központ -Orszagos Haemophilia Kozpont | Budapest | H-1134 | Hungary |
| Azienda Ospedaliera-Universitaria Parma | Parma | 43126 | Italy |
| Policlinico Umberto I Sezione Ematologia | Roma | 00161 | Italy |
| A.O.U Città Salute Scienza Torino | Torino | 10126 | Italy |
| Ospedale San Bortolo | Vicenza | 36100 | Italy |
| Hospital of LUHS "Kauno Klinikos" | Kaunas | LT-50161 | Lithuania |
| Republican Panevezys Hospital, Public consultation clinic | Panevezys | LT-35144 | Lithuania |
| Vilnius University hospital Santaros klinikos | Vilnius | 08661 | Lithuania |
| Vilnius University hospital Santaros klinikos | Vilnius | LT-08661 | Lithuania |
| Centro Hospitalar Lisboa Norte-HSM | Lisbon | 1649-035 | Portugal |
| ULS São João, E.P.E. | Porto | 4200-319 | Portugal |
| Unilabs Slovensko, s. r. o. | Košice | 04011 | Slovakia |
| PeK - University Children's Hospital, Department of haematology | Ljubljana | 1000 | Slovenia |
| Hospital Regional Universitario de Málaga | Málaga | 29009 | Spain |
| Kinderspital Hämatologie, Zürich | Zurich | 8032 | Switzerland |
| 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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