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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Females With Severe or Moderate Hemophilia A or B: an International Multi-center Study
Secondary ID [1] 0 0
Intl Female Hemophilia Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemophilia A 0 0
Hemophilia B 0 0
Condition category
Condition code
Blood 0 0 0 0
Clotting disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
1-2 visits

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.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects who do not meet the inclusion criteria with respect to gender or hemophilia severity.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2011
Sample size
Target
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Germany
State/province [2] 0 0
Bonn
Country [3] 0 0
Germany
State/province [3] 0 0
Munich
Country [4] 0 0
Israel
State/province [4] 0 0
Tel Hashomer
Country [5] 0 0
Italy
State/province [5] 0 0
Genova
Country [6] 0 0
Italy
State/province [6] 0 0
Milan
Country [7] 0 0
Japan
State/province [7] 0 0
Nara
Country [8] 0 0
Netherlands
State/province [8] 0 0
Utrecht
Country [9] 0 0
Sweden
State/province [9] 0 0
Malmo
Country [10] 0 0
Taiwan
State/province [10] 0 0
Changhua

Funding & Sponsors
Primary sponsor type
Other
Name
Weill Medical College of Cornell University
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bayer
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University Hospital, Bonn
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00936312
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
William B Mitchell, MD
Address 0 0
Weill Medical College of Cornell University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00936312