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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00936312
Registration number
NCT00936312
Ethics application status
Date submitted
9/07/2009
Date registered
10/07/2009
Date last updated
10/12/2012
Titles & IDs
Public title
Females With Severe or Moderate Hemophilia A or B: an International Multi-center Study
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Scientific title
Females With Severe or Moderate Hemophilia A or B: an International Multi-center Study
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Secondary ID [1]
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Intl Female Hemophilia Study
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hemophilia A
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Hemophilia B
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Condition category
Condition code
Blood
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Clotting disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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1-2 visits
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Eligibility
Key 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.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subjects who do not meet the inclusion criteria with respect to gender or hemophilia
severity.
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2011
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Sample size
Target
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Accrual to date
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Final
200
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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- Perth
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Recruitment outside Australia
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United States of America
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State/province [1]
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New York
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Country [2]
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Germany
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State/province [2]
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Bonn
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Country [3]
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Germany
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State/province [3]
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Munich
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Country [4]
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Israel
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State/province [4]
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Tel Hashomer
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Country [5]
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Italy
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State/province [5]
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Genova
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Italy
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Milan
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Japan
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State/province [7]
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Nara
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Country [8]
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Netherlands
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State/province [8]
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Utrecht
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Country [9]
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Sweden
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State/province [9]
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Malmo
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Country [10]
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Taiwan
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State/province [10]
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Changhua
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Funding & Sponsors
Primary sponsor type
Other
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Name
Weill Medical College of Cornell University
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Bayer
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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University Hospital, Bonn
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Address [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00936312
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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William B Mitchell, MD
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Address
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Weill Medical College of Cornell University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00936312
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