Project to Update the Study of Congenital Haemophilia in Spain

Study Overview
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Brief Summary
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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.

Official Title
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Project to Update the Study of Congenital Haemophilia in Spain

Conditions
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Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

Intervention / Treatment
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* Other: No treatment given


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol) Male patients of any age diagnosed with congenital haemophilia A or B who visited their HTC at least once during the period of January 2013 to December 2013 Exclusion Criteria: Previous participation in this study Female patients Acquired haemophilia
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective collection of data<br> | Other: No treatment given<br>* Patients will not be treated with any specific product. Data collection only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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) |