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

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Completed
CT.gov ID
NCT00936312
Collaborator
Bayer (Industry), University Hospital, Bonn (Other)
200
Enrollment
11
Locations
41
Duration (Months)
18.2
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Females With Severe or Moderate Hemophilia A or B: an International Multi-center Study
    Study Start Date :
    Mar 1, 2008
    Actual Primary Completion Date :
    Aug 1, 2011
    Actual Study Completion Date :
    Aug 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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. [1-2 visits]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Weill Cornell Medical College New York New York United States 10065
    2 Princess Margaret Hospital for Children Perth Australia
    3 University Clinic Bonn Bonn Germany
    4 University Clinic Munich Munich Germany
    5 Sheba Medical Center Tel Hashomer Israel
    6 Instituto G. Gaslini Genova Italy
    7 A. Bianchi Bonomi Hemophilia Center Milan Italy
    8 Nara Medical University Nara Japan
    9 University Hospital Utrecht Utrecht Netherlands
    10 Malmo University Hospital Malmo Sweden
    11 Changhua Christian Hospital Chunghua City Changhua Taiwan

    Sponsors and Collaborators

    • Weill Medical College of Cornell University
    • Bayer
    • University Hospital, Bonn

    Investigators

    • Principal Investigator: William B Mitchell, MD, Weill Medical College of Cornell University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Weill Medical College of Cornell University
    ClinicalTrials.gov Identifier:
    NCT00936312
    Other Study ID Numbers:
    • Intl Female Hemophilia Study
    First Posted:
    Jul 10, 2009
    Last Update Posted:
    Dec 10, 2012
    Last Verified:
    Dec 1, 2012
    Additional relevant MeSH terms:
    Hemophilia A
    Hemophilia B

    Study Results

    No Results Posted as of Dec 10, 2012