Brief Title
Females With Severe or Moderate Hemophilia A or B: an International Multi-center Study
Official Title
Females With Severe or Moderate Hemophilia A or B: an International Multi-center Study
Brief Summary
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.
Detailed 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.
Study Type
Observational
Primary Outcome
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.
Condition
Hemophilia A
Study Arms / Comparison Groups
Females with Hemophilia
Description: Females with severe or moderate Hemophilia A or B
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
200
Start Date
March 2008
Completion Date
August 2011
Primary Completion Date
August 2011
Eligibility Criteria
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.
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
William B Mitchell, MD, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00936312
Organization ID
Intl Female Hemophilia Study
Responsible Party
Sponsor
Study Sponsor
Weill Medical College of Cornell University
Collaborators
Bayer
Study Sponsor
William B Mitchell, MD, Principal Investigator, Weill Medical College of Cornell University
Verification Date
December 2012