Project to Update the Study of Congenital Haemophilia in Spain

Completed

• Conditions: Haemophilia A; Congenital Bleeding Disorder; Haemophilia B
• Interventions: Other: No treatment given

• Registration Number: NCT01959555
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-10
• Study Start: 2014-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-27
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1157

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

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Exclusion Criteria

• Previous participation in this study
• Female patients
• Acquired haemophilia

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective collection of data	No treatment given	-

Primary Outcome Measures

Name	Time	Method
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)
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)

Secondary Outcome Measures

Name	Time	Method
Mean current age at the time of visit to the HTC 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/without genetic screening performed	Assessed at study visit (day 1)
Proportion (%) of patients who received on demand or prophylaxis treatment	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 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)
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 infectious complications	Assessed 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)
Proportion (%) of patients with treatment administered at home	Assessed at study visit (day 1)
Mean age at diagnosis	Assessed at study visit (day 1)
Proportion (%) of patients with established arthropathy	Assessed at study visit (day 1)