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Study Evaluating Approach to Treatment of Haemophilia A and B in Spain
This study has been completed.
Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00581438
  Purpose

Analyze the clinical and therapeutic approach to treatment of haemophilia A and B in habitual clinical practice conditions in Spain.


Condition
Hemophilia A
Hemophilia B

Genetics Home Reference related topics: hemophilia L1 syndrome
MedlinePlus related topics: Hemophilia
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Retrospective
Official Title: Actual Approach to Treatment of Haemophilia A and B in Spain

Further study details as provided by Wyeth:

Primary Outcome Measures:
  • Analyze the clinical and therapeutic approach to treament of haemophilia A and B in habitual clinical practice conditions in Spain during the first 3 years since diagnosis. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess haemophilia A or B patient profile, study different kinds of habitual clinical treatment of haemophilia A and B patients, and estimate the dosage units used per year in patients under habitual clinical practice conditions. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 52
Study Start Date: June 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1

Detailed Description:

Analyze the clinical and therapeutic approach to treatment of haemophilia A and B in habitual clinical practice conditions in Spain during the first 3 years since diagnosis.

Assess haemophilia A or B patient profile, study different kinds of hanitual clinical treatment of haemophilia A and B patients, and estimate the kind of treatment and dosage units used per year in patients under habitual clinical practice conditions.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People known to have Haemophilia A or B

Criteria

Inclusion Criteria:

  • Haemophilia A or B patients of any age
  • Written informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581438

Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
  More Information

Responsible Party: Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers: 3082A-102378
Study First Received: December 21, 2007
Last Updated: December 26, 2007
ClinicalTrials.gov Identifier: NCT00581438  
Health Authority: Spain: Ministry of Health;   Spain: Ministry of Health and Consumption;   Spain: Spanish Agency of Medicines

Keywords provided by Wyeth:
Approach Haemophilia A and B

Study placed in the following topic categories:
Hemophilia B
Hemorrhagic Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Blood Coagulation Disorders
Hemophilia A
Genetic Diseases, X-Linked
Hemostatic Disorders

Additional relevant MeSH terms:
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders

ClinicalTrials.gov processed this record on January 13, 2009