PUCHS: Project to Update the Study of Congenital Haemophilia in Spain
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Retrospective collection of data
|
Other: No treatment given
Patients will not be treated with any specific product. Data collection only.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Madrid | Spain | 28033 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- HAEM-4076
- U1111-1136-7052
- NOV-HEM-2013-01