Project to Update the Study of Congenital Haemophilia in Spain

NCT01959555 | Completed

• 3 other identifiers: HAEM-4076U1111-1136-7052NOV-HEM-2013-01
• Study Type: observational
• Target: 1,157
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Bleeding Disorder; Haemophilia A; Haemophilia B

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• 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)

Study Arms (1)

Retrospective collection of data

Other: No treatment given

Interventions

No treatment given OTHER

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

Retrospective collection of data

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Madrid, 28033, Spain

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 10, 2013
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 30, 2015

Record last verified: 2015-11

Locations

ES (1)