Status:
COMPLETED
The Second Multicenter Hemophilia Cohort Study
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
Multicenter Hemophilia Cohort Study
Conditions:
Liver Decompensation
Hepatocellular Carcinoma
Eligibility:
All Genders
13+ years
Brief Summary
The Second Multicenter Hemophilia Cohort Study (MHCS-II) will evaluate and prospectively follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus (HCV). The vast majorit...
Detailed Description
The Second Multicenter Hemophilia Cohort Study (MHCS-II) will evaluate and prospectively follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus (HCV). The vast majorit...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Must be registered patient with an inherited coagulation disorder at a participating MHCS-II center. Disorders include hemophilia A or B (congenital factor VIII or IX deficiency), deficiencies in other factors such as V or XI, and vonWillebrand's disease. (Unless noted otherwise, all of the disorders will collectively be referred to as hemophilia .) All such hemophilia and vonWillebrand s disease patients are to be recruited as study participants.
- Since January 1, 1993, must have had at least one positive result on a licensed assay for HCV antibodies, HIV antibodies, or HIV RNA.
- Must be at least 13 years of age at enrollment.
- Must provide signed informed consent or, for minors, signed assent plus signed informed consent from the parent or guardian.
- EXCLUSION CRITERIA:
- Is not a patient with an inherited coagulation disorder.
- Does not have a positive test for HCV antibodies, HIV antibodies, or HIV RNA on a licensed assay performed since January 1, 1993.
- Is less than 13 years of age.
- Lacks informed consent/assent.
Exclusion
Key Trial Info
Start Date :
April 27 2001
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 2 2013
Estimated Enrollment :
2565 Patients enrolled
Trial Details
Trial ID
NCT00341705
Start Date
April 27 2001
End Date
April 2 2013
Last Update
December 17 2019
Active Locations (48)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
University of California, Davis
Davis, California, United States, 95616
3
Children's Hospital of Orange County
Orange, California, United States, 92613
4
University of California, San Francisco
San Francisco, California, United States, 94143