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

NCT ID: NCT00936312

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-08-31

Brief Summary

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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

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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.

Conditions

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Hemophilia A Hemophilia B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Females with Hemophilia

Females with severe or moderate Hemophilia A or B

No interventions assigned to this group

Control group

Male subjects with severe Hemophilia A or B and female subjects with mild (20-60%) Hemophilia A or B.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

University Hospital, Bonn

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William B Mitchell, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medical College

New York, New York, United States

Site Status

Princess Margaret Hospital for Children

Perth, , Australia

Site Status

University Clinic Bonn

Bonn, , Germany

Site Status

University Clinic Munich

Munich, , Germany

Site Status

Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Instituto G. Gaslini

Genova, , Italy

Site Status

A. Bianchi Bonomi Hemophilia Center

Milan, , Italy

Site Status

Nara Medical University

Nara, , Japan

Site Status

University Hospital Utrecht

Utrecht, , Netherlands

Site Status

Malmo University Hospital

Malmo, , Sweden

Site Status

Changhua Christian Hospital

Chunghua City, Changhua, Taiwan

Site Status

Countries

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United States Australia Germany Israel Italy Japan Netherlands Sweden Taiwan

Other Identifiers

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Intl Female Hemophilia Study

Identifier Type: -

Identifier Source: org_study_id