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Completed

NCT Number: NCT01959555

Project to Update the Study of Congenital Haemophilia in Spain

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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Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Haemophilia A Haemophilia B Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemophilia B Hemorrhagic Disorders

Sex eligibility

Male

Study type

Observational

Primary location

Madrid, 28033, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No treatment given

Other

Patients will not be treated with any specific product. Data collection only.

Primary outcomes

  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)

    Time frame: Assessed at study visit (day 1)

  2. 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

    Time frame: Assessed at study visit (day 1)

Secondary outcomes

  1. Mean current age at the time of visit to the HTC in 2013

    Time frame: Assessed at study visit (day 1)

  2. Mean age at diagnosis

    Time frame: Assessed at study visit (day 1)

  3. Proportion (%) of patients with/without genetic screening performed

    Time frame: Assessed at study visit (day 1)

  4. Proportion (%) of patients who needed support of a reference Haemophilia Healthcare Centre in 2013

    Time frame: Assessed at study visit (day 1)

  5. Proportion (%) of patients who received plasmatic or recombinant treatment

    Time frame: Assessed at study visit (day 1)

  6. Proportion (%) of patients who received on demand or prophylaxis treatment

    Time frame: Assessed at study visit (day 1)

  7. Mean number of bleeding episodes

    Time frame: Assessed at study visit (day 1)

  8. Mean number of joint bleeds

    Time frame: Assessed at study visit (day 1)

  9. Proportion (%) of patients with established arthropathy

    Time frame: Assessed at study visit (day 1)

  10. Proportion (%) of patients with infectious complications

    Time frame: Assessed at study visit (day 1)

  11. Proportion (%) of patients with HIV (Human immunodeficiency virus)

    Time frame: Assessed at study visit (day 1)

  12. Proportion (%) of patients with presence of inhibitors

    Time frame: Assessed at study visit (day 1)

  13. Proportion (%) of patients with immune tolerance induction treatment performed

    Time frame: Assessed at study visit (day 1)

  14. Total number of surgery interventions performed

    Time frame: ThAssessed at study visit (day 1)

  15. Proportion (%) of patients with quality of life questionnaire (QoLQ) performed in 2013

    Time frame: Assessed at study visit (day 1)

  16. Mean number of days of absenteeism to school/university in children and adolescents in 2013

    Time frame: Assessed at study visit (day 1)

  17. Mean number of days of absenteeism from work in 2013

    Time frame: Assessed at study visit (day 1)

  18. Proportion (%) of patients with treatment administered at home

    Time frame: Assessed at study visit (day 1)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Acronym: PUCHS

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 10, 2013
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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