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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00936845
First Posted: July 10, 2009
Last Update Posted: December 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
CSL Behring
University of Pennsylvania
Information provided by (Responsible Party):
Weill Medical College of Cornell University
July 9, 2009
July 10, 2009
December 10, 2012
April 2005
January 2010   (Final data collection date for primary outcome measure)
The prevalence of females with severe or moderate hemophilia A or B in the United States. [ Time Frame: Study Duration ]
The prevalence of females with severe or moderate hemophilia A or B in the United States.
Complete list of historical versions of study NCT00936845 on ClinicalTrials.gov Archive Site
  • Collect existing data on the genetic and/or chromosomal causes for severe and moderate hemophilia A and B in females in the United States. [ Time Frame: Study Duration ]
  • To determine the natural history of hemophilia in females by collecting and analyzing data on the symptoms, treatment patterns, and complications of hemophilia in this cohort. [ Time Frame: Study Duration ]
  • Collect and analyze data on the health-related quality of life and psychosocial adaptation to disease of females in the United States. [ Time Frame: Study Duration ]
  • Collect existing data on the genetic and/or chromosomal causes for severe and moderate hemophilia A and B in females in the United States.
  • To determine the natural history of hemophilia in females by collecting and analyzing data on the symptoms, treatment patterns, and complications of hemophilia in this cohort.
  • Collect and analyze data on the health-related quality of life and psychosocial adaptation to disease of females in the United States.
Not Provided
Not Provided
 
Females With Severe or Moderate Hemophilia A or B: A Multi-Center Study
Females With Severe or Moderate Hemophilia A or B: A Multi-Center Study
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
Females with severe or moderate (less than 5%) hemophilia A or B.
  • Hemophilia A
  • Hemophilia B
Not Provided
Females with Hemophilia
Females with severe or moderate Hemophilia A or B.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
January 2010
January 2010   (Final data collection date for primary outcome measure)

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.

Exclusion Criteria:

  • Subjects who do not meet the inclusion criteria with respect to gender or hemophilia severity.
Sexes Eligible for Study: Female
1 Month and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00936845
Females with Hemophilia
No
Not Provided
Not Provided
Weill Medical College of Cornell University
Weill Medical College of Cornell University
  • CSL Behring
  • University of Pennsylvania
Principal Investigator: William B Mitchell, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
December 2012