Congenital Bleeding Disorder Clinical Trial
— PUCHSOfficial title:
Project to Update the Study of Congenital Haemophilia in Spain
Verified date | November 2015 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Spanish Agency of Medicines |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1157 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility |
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 |
Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No | |
Primary | 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) | No | |
Secondary | Mean current age at the time of visit to the HTC in 2013 | Assessed at study visit (day 1) | No | |
Secondary | Mean age at diagnosis | Assessed at study visit (day 1) | No | |
Secondary | Proportion (%) of patients with/without genetic screening performed | Assessed at study visit (day 1) | No | |
Secondary | Proportion (%) of patients who needed support of a reference Haemophilia Healthcare Centre in 2013 | Assessed at study visit (day 1) | No | |
Secondary | Proportion (%) of patients who received plasmatic or recombinant treatment | Assessed at study visit (day 1) | No | |
Secondary | Proportion (%) of patients who received on demand or prophylaxis treatment | Assessed at study visit (day 1) | No | |
Secondary | Mean number of bleeding episodes | Assessed at study visit (day 1) | No | |
Secondary | Mean number of joint bleeds | Assessed at study visit (day 1) | No | |
Secondary | Proportion (%) of patients with established arthropathy | Assessed at study visit (day 1) | No | |
Secondary | Proportion (%) of patients with infectious complications | Assessed at study visit (day 1) | No | |
Secondary | Proportion (%) of patients with HIV (Human immunodeficiency virus) | Assessed at study visit (day 1) | No | |
Secondary | Proportion (%) of patients with presence of inhibitors | Assessed at study visit (day 1) | No | |
Secondary | Proportion (%) of patients with immune tolerance induction treatment performed | Assessed at study visit (day 1) | No | |
Secondary | Total number of surgery interventions performed | ThAssessed at study visit (day 1) | No | |
Secondary | Proportion (%) of patients with quality of life questionnaire (QoLQ) performed in 2013 | Assessed at study visit (day 1) | No | |
Secondary | Mean number of days of absenteeism to school/university in children and adolescents in 2013 | Assessed at study visit (day 1) | No | |
Secondary | Mean number of days of absenteeism from work in 2013 | Assessed at study visit (day 1) | No | |
Secondary | Proportion (%) of patients with treatment administered at home | Assessed at study visit (day 1) | No |
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