Females With Severe or Moderate Hemophilia A or B: an International Multi-center Study
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Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Volunteers
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.
Trial design
200 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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