Females With Severe or Moderate Hemophilia A or B: A Multi-Center Study

NCT ID: NCT00936845

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

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2010-01-31

Brief Summary

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To collect and analyze data on females with hemophilia so as to better define the difference between the study population and the male population with hemophilia.

Detailed Description

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This study is designed as an epidemiological study with retrospective clinical and genetic data collection and prospective quality of life (QOL) data collections and genotyping of subjects without current molecular diagnosis. Data on the genetic/chromosomal etiology of the condition will be collected through chart review. For those subjects who have not had molecular or cytogenetic analysis, molecular and cytogenetic testing will be offered after genetic counseling. Those subjects who agree to have genetic testing will have 5-10 ml of blood drawn and sent to the cytogenetic laboratory at Weill Cornell Medical College for testing to determine the chromosomal complement, and 5 ml of blood sent to Dr. Arupa Ganguly at the University of Pennsylvania for the identification of a factor VIII or factor IX mutation, and X-chromosome inactivation studies.

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

Eligibility Criteria

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Inclusion Criteria

* Females with severe (FVIII\<0.01u/dl) or moderate (FVIII-0.01\<0.06 u/dl) hemophilia A
* Females with severe (FIX\<0.01u/dl) or moderate (FIX-0.01\<0.06u/dl) hemophilia B
* Willingness to participate in the study.
Minimum Eligible Age

1 Month

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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CSL Behring

INDUSTRY

Sponsor Role collaborator

University of Pennsylvania

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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City of Hope National Medical Center

Duarte, California, United States

Site Status

Mountain States Regional Hemophilia and Thrombosis Center

Aurora, Colorado, United States

Site Status

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

Emory University Hemophilia Program Office

Atlanta, Georgia, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

University of Kentucky Hemophilia Treatment Center

Lexington, Kentucky, United States

Site Status

Boston Hemophilia Center- Children's Hospital

Boston, Massachusetts, United States

Site Status

Henry Ford Hospital Adult Hemophilia and Thrombosis Treatment Center

Detroit, Michigan, United States

Site Status

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status

Hemophilia Center of Western New York - Pediatric

Buffalo, New York, United States

Site Status

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

Mary M. Gooley Hemophilia Center, Inc.

Rochester, New York, United States

Site Status

Children's Hospital Medical Center of Akron

Akron, Ohio, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Oklahoma Center for Bleeding Disorders

Oklahoma City, Oklahoma, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Gulf States Hemophilia and Thrombophilia Center

Houston, Texas, United States

Site Status

Puerto Rico Hemophilia Treatment Center

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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Females with Hemophilia

Identifier Type: -

Identifier Source: org_study_id