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Project to Update the Study of Congenital Haemophilia in Spain (PUCHS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01959555
First Posted: October 10, 2013
Last Update Posted: November 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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 Intervention
Congenital Bleeding Disorder Haemophilia A Haemophilia B Other: No treatment given

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Project to Update the Study of Congenital Haemophilia in Spain

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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) [ Time Frame: 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 [ Time Frame: Assessed at study visit (day 1) ]

Secondary Outcome Measures:
  • Mean current age at the time of visit to the HTC in 2013 [ Time Frame: Assessed at study visit (day 1) ]
  • Mean age at diagnosis [ Time Frame: Assessed at study visit (day 1) ]
  • Proportion (%) of patients with/without genetic screening performed [ Time Frame: Assessed at study visit (day 1) ]
  • Proportion (%) of patients who needed support of a reference Haemophilia Healthcare Centre in 2013 [ Time Frame: Assessed at study visit (day 1) ]
  • Proportion (%) of patients who received plasmatic or recombinant treatment [ Time Frame: Assessed at study visit (day 1) ]
  • Proportion (%) of patients who received on demand or prophylaxis treatment [ Time Frame: Assessed at study visit (day 1) ]
  • Mean number of bleeding episodes [ Time Frame: Assessed at study visit (day 1) ]
  • Mean number of joint bleeds [ Time Frame: Assessed at study visit (day 1) ]
  • Proportion (%) of patients with established arthropathy [ Time Frame: Assessed at study visit (day 1) ]
  • Proportion (%) of patients with infectious complications [ Time Frame: Assessed at study visit (day 1) ]
  • Proportion (%) of patients with HIV (Human immunodeficiency virus) [ Time Frame: Assessed at study visit (day 1) ]
  • Proportion (%) of patients with presence of inhibitors [ Time Frame: Assessed at study visit (day 1) ]
  • Proportion (%) of patients with immune tolerance induction treatment performed [ Time Frame: Assessed at study visit (day 1) ]
  • Total number of surgery interventions performed [ Time Frame: ThAssessed at study visit (day 1) ]
  • Proportion (%) of patients with quality of life questionnaire (QoLQ) performed in 2013 [ Time Frame: Assessed at study visit (day 1) ]
  • Mean number of days of absenteeism to school/university in children and adolescents in 2013 [ Time Frame: Assessed at study visit (day 1) ]
  • Mean number of days of absenteeism from work in 2013 [ Time Frame: Assessed at study visit (day 1) ]
  • Proportion (%) of patients with treatment administered at home [ Time Frame: Assessed at study visit (day 1) ]

Enrollment: 1157
Study Start Date: March 2014
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Retrospective collection of data Other: No treatment given
Patients will not be treated with any specific product. Data collection only.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in active follow-up in HTCs (Haemophilia Treatment Centres) will be included in this study. A patient is considered as active if a visit to the HTC is performed in the period of January 2013 to December 2013.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959555


Locations
Spain
Madrid, Spain, 28033
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01959555     History of Changes
Other Study ID Numbers: HAEM-4076
U1111-1136-7052 ( Other Identifier: WHO )
NOV-HEM-2013-01 ( Other Identifier: Novo Nordisk )
First Submitted: October 8, 2013
First Posted: October 10, 2013
Last Update Posted: November 30, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases