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

December 6, 2012 updated by: Weill Medical College of Cornell University
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Perth, Australia
        • Princess Margaret Hospital for Children
  • Germany
      • Bonn, Germany
        • University Clinic Bonn
      • Munich, Germany
        • University Clinic Munich
  • Israel
      • Tel Hashomer, Israel
        • Sheba Medical Center
  • Italy
      • Genova, Italy
        • Instituto G. Gaslini
      • Milan, Italy
        • A. Bianchi Bonomi Hemophilia Center
  • Japan
      • Nara, Japan
        • Nara Medical University
  • Netherlands
      • Utrecht, Netherlands
        • University Hospital Utrecht
  • Sweden
      • Malmo, Sweden
        • Malmö University Hospital
  • Taiwan
    • Changhua
      • Chunghua City, Changhua, Taiwan
        • Changhua Christian Hospital
  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Females with severe or moderate Hemophilia A (less than or equal to 5%) Females with severe or moderate Hemophilia B (less than or equal to 5%)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 1-2 visits
1-2 visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Bayer
University Hospital, Bonn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

July 9, 2009

First Posted (ESTIMATE)

July 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2012

Last Update Submitted That Met QC Criteria

December 6, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Intl Female Hemophilia Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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