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The study has descriptive purposes, with aim of assessing how turoctocog alfa is used in the everyday practice and to provide a baseline for the management of haemophilia A and does not involve any change in the clinical management of participants. Data will be extrapolated from the existing paper based medical records and uploaded to an electronic database specifically created for the study. Baseline information/history will be recorded at time of switching from previous FVIII replacement therapy to turoctocog alfa from the enrolled participants and outcomes will be collected according to participants visit format.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Turoctocog alfa | Participants received turoctocog alfa intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Turoctocog alfa | Drug | Turoctocog alfa was administered intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annual bleeding Rate (ABRs) among patients treated with different regimen of turoctocog alfa after previous FVIII replacement therapy | Measured as count of all reported bleeding events divided by the number of months in the reporting time window (8 weeks to 12 months) and multiplied by 12. | From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa |
| Measure | Description | Time Frame |
|---|---|---|
| ABRs among patients treated with different regimen of turoctocog alfa after previous FVIII replacement therapy | Measured as number of all reported bleeding events divided by the number of months in the reporting time window (8 weeks to 12 months) and multiplied by 12 across 4 age segments ( less than [<] 8 years, 8-14 years, 15-18 years, greater than [>] 18 years). | From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa |
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Inclusion Criteria:
Exclusion Criteria:
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Participants received Turoctocog alfa intravenously.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National centre for Hamophilia | Baghdad | 10001 | Iraq | |||
| Novo Nordisk Investigational Site |
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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| ID | Term |
|---|---|
| C577506 | recombinant factor VIII N8 |
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| Change of primary prophylaxis regimen | Measured as Yes/No. | From baseline (first day of receiving turoctocog alpha) to month 12 after switching to turoctocog alfa |
| Dose of turoctocog alfa | Measured as international uniit per kilogram (IU/kg). | At month 12 after switching to turoctocog alfa |
| Haemostatic response to turoctocog alfa | Measured as excellent, good, moderate, none. | At baseline and at month 12 |
| Spontaneous ABR | Measured as number of reported spontaneous bleeding events divided by the number of months in the reporting time window (8 weeks to 12 months) and multiplied by 12. | At month 12 after switching to turoctocog alfa |
| Annualized joint bleed rate (AJBR) | Measured as number of reported joint bleeding episodes divided by the observation period in months multiplied by 12. | At month 12 after switching to turoctocog alfa |
| New target joint | Measured as number resolution (Yes/No) affected joints. | At month 12 after switching to turoctocog alfa |
| Severity of bleeding | Measured as mild / moderate / severe. | At month 12 after switching to turoctocog alfa |
| Baghdad |
| Iraq |
| Basrah Haemoplhilia centre | Basra | 61001 | Iraq |
| Hilla Haemophilia centre | Hillah | 51001 | Iraq |
| Karbala Haemophilia centre | Karbala | 56001 | Iraq |
| Kirkuk Centre for Cancer and Blood Disorders | Kirkuk | 36001 | Iraq |
| Najaf Haemophilia Centre | Najaf | 54001 | Iraq |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |