Females With Severe or Moderate Hemophilia A or B: A Multi-Center Study
1 other identifier
observational
22
2 countries
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2005
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 9, 2009
CompletedFirst Posted
Study publicly available on registry
July 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedDecember 10, 2012
December 1, 2012
4.8 years
July 9, 2009
December 6, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
The prevalence of females with severe or moderate hemophilia A or B in the United States.
Study Duration
Secondary Outcomes (3)
Collect existing data on the genetic and/or chromosomal causes for severe and moderate hemophilia A and B in females in the United States.
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.
Study Duration
Collect and analyze data on the health-related quality of life and psychosocial adaptation to disease of females in the United States.
Study Duration
Study Arms (1)
Females with Hemophilia
Females with severe or moderate Hemophilia A or B.
Eligibility Criteria
Females with severe or moderate (less than 5%) hemophilia A or B.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Weill Medical College of Cornell Universitylead
- CSL Behringcollaborator
- University of Pennsylvaniacollaborator
Study Sites (19)
City of Hope National Medical Center
Duarte, California, 91010, United States
Mountain States Regional Hemophilia and Thrombosis Center
Aurora, Colorado, 80045, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Emory University Hemophilia Program Office
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Kentucky Hemophilia Treatment Center
Lexington, Kentucky, 40536, United States
Boston Hemophilia Center- Children's Hospital
Boston, Massachusetts, 02115, United States
Henry Ford Hospital Adult Hemophilia and Thrombosis Treatment Center
Detroit, Michigan, 48202, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Hemophilia Center of Western New York - Pediatric
Buffalo, New York, 14222, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Mary M. Gooley Hemophilia Center, Inc.
Rochester, New York, 14621, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Oklahoma Center for Bleeding Disorders
Oklahoma City, Oklahoma, 73104, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Gulf States Hemophilia and Thrombophilia Center
Houston, Texas, 77030, United States
Puerto Rico Hemophilia Treatment Center
San Juan, 00936, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William B Mitchell, MD
Weill Medical College of Cornell University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2009
First Posted
July 10, 2009
Study Start
April 1, 2005
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
December 10, 2012
Record last verified: 2012-12