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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1136-7052 | Other Identifier | WHO | |
| NOV-HEM-2013-01 | Other Identifier | Novo Nordisk |
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This study is conducted in Europe. The aim of the study is to update the knowledge about the prevalence and severity of congenital haemophilia (A and B) in Spain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective collection of data |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment given | Other | Patients will not be treated with any specific product. Data collection only. |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of congenital haemophilia A and B in Spain in 2013, described as proportion (%) of patients in the total population (extracted from the last available census of the Spanish population for the regions considered for the study) | Assessed at study visit (day 1) | |
| Severity (mild, moderate or severe) of congenital haemophilia A and B in Spain during 2013, described as proportion (%) per category of the total number of patients with haemophilia A or B | Assessed at study visit (day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean current age at the time of visit to the HTC in 2013 | Assessed at study visit (day 1) | |
| Mean age at diagnosis | Assessed at study visit (day 1) | |
| Proportion (%) of patients with/without genetic screening performed |
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Inclusion Criteria:
Exclusion Criteria:
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Patients in active follow-up in HTCs (Haemophilia Treatment Centres) will be included in this study. A patient is considered as active if a visit to the HTC is performed in the period of January 2013 to December 2013.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madrid | 28033 | Spain |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| 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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| Assessed at study visit (day 1) |
| Proportion (%) of patients who needed support of a reference Haemophilia Healthcare Centre in 2013 | Assessed at study visit (day 1) |
| Proportion (%) of patients who received plasmatic or recombinant treatment | Assessed at study visit (day 1) |
| Proportion (%) of patients who received on demand or prophylaxis treatment | Assessed at study visit (day 1) |
| Mean number of bleeding episodes | Assessed at study visit (day 1) |
| Mean number of joint bleeds | Assessed at study visit (day 1) |
| Proportion (%) of patients with established arthropathy | Assessed at study visit (day 1) |
| Proportion (%) of patients with infectious complications | Assessed at study visit (day 1) |
| Proportion (%) of patients with HIV (Human immunodeficiency virus) | Assessed at study visit (day 1) |
| Proportion (%) of patients with presence of inhibitors | Assessed at study visit (day 1) |
| Proportion (%) of patients with immune tolerance induction treatment performed | Assessed at study visit (day 1) |
| Total number of surgery interventions performed | ThAssessed at study visit (day 1) |
| Proportion (%) of patients with quality of life questionnaire (QoLQ) performed in 2013 | Assessed at study visit (day 1) |
| Mean number of days of absenteeism to school/university in children and adolescents in 2013 | Assessed at study visit (day 1) |
| Mean number of days of absenteeism from work in 2013 | Assessed at study visit (day 1) |
| Proportion (%) of patients with treatment administered at home | Assessed at study visit (day 1) |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |