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Females With Severe or Moderate Hemophilia A or B: an International Multi-center Study

This study has been completed.
Sponsor:
Collaborators:
Bayer
University Hospital, Bonn
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00936312
First received: July 9, 2009
Last updated: December 6, 2012
Last verified: December 2012
History of Changes

July 9, 2009
December 6, 2012
March 2008
August 2011   (final data collection date for primary outcome measure)
The molecular and cytogenetic etiology of the condition will be compiled. Clinical manifestation demonstrated by the female hemophiliacs will be compared to published data available. Genotype and phenotype will be correlated. [ Time Frame: 1-2 visits ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00936312 on ClinicalTrials.gov Archive Site
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Females With Severe or Moderate Hemophilia A or B: an International Multi-center Study
Females With Severe or Moderate Hemophilia A or B: an International Multi-center Study

This is a multi-center, international study designed to collect clinical, genetic and quality of life information on females with hemophilia, an inherited bleeding disorder. The study is designed to determine whether there are problems and issues unique to females with hemophilia.

The study involves two questionnaires: one on the diagnosis, symptoms, complications and treatment of each participant to be completed by a staff member; the other is a questionnaire to be completed by the participant on how the disease has affected her life. Finally, for those participants who have not previously had genetic testing, the third part of the study is an optional blood test to determine the genetic cause, what change in the factor VIII or factor IX gene, caused the hemophilia. The test results will be available to those participants who wish to learn their results. With the data we collect we will compile a database to examine the connection between the genetic cause of hemophilia and the course and symptoms of the disease.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Females with severe or moderate Hemophilia A (less than or equal to 5%) Females with severe or moderate Hemophilia B (less than or equal to 5%)
  • Hemophilia A
  • Hemophilia B
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  • Females with Hemophilia
    Females with severe or moderate Hemophilia A or B
  • Control group
    Male subjects with severe Hemophilia A or B and female subjects with mild (20-60%) Hemophilia A or B.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Females with severe (FVIII<0.01u/ml) or moderate (FVIII 0.01≤0.05 u/ml) hemophilia A
  • Females with severe (FIX<0.01u/ml) or moderate (FIX 0.01≤0.05u/ml) hemophilia B
  • Willingness to participate in the study.

Exclusion Criteria:

  • Subjects who do not meet the inclusion criteria with respect to gender or hemophilia severity.
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Germany,   Israel,   Italy,   Japan,   Netherlands,   Sweden,   Taiwan
 
NCT00936312
Intl Female Hemophilia Study
No
Weill Medical College of Cornell University
Weill Medical College of Cornell University
  • Bayer
  • University Hospital, Bonn
Principal Investigator: William B Mitchell, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP