The Second Multicenter Hemophilia Cohort Study
13 Years
N/A
Both
Liver Decompensation, Hepatocellular Carcinoma, Non-Hodgkin Lymphoma
Trial Information
The Second Multicenter Hemophilia Cohort Study
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 majority will have been infected with HCV, and approximately 1/3 will have
been infected with human immunodeficiency virus (HIV). Primary objectives are to quantify
the rates of liver decompensation, hepatocellular carcinoma, and non-Hodgkin lymphoma and to
evaluate candidate clinical, genetic, virologic, serologic and immunologic markers that are
likely to be on the causal pathway for these conditions. Candidate clinical and laboratory
markers will be examined longitudinally to define changes over time and their relationships
to one another. Collaborative studies will focus on genome scanning and evaluation of
candidate genetic loci for susceptibility or resistance to HCV and HIV infections or to the
diseases that result from these infections. Additional studies will identify response and
complication rates of various anti-HCV and anti-HIV regimens in the setting of comprehensive
clinical care of persons with hemophilia.
Inclusion Criteria
- 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.
Type of Study:
Observational
Study Design:
N/A
Principal Investigator
Wyndham H Wilson, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
999901170
NCT ID:
NCT00341705
Start Date:
April 2001
Completion Date:
April 2013
Related Keywords:
- Liver Decompensation
- Hepatocellular Carcinoma
- Non-Hodgkin Lymphoma
- AIDS
- Cancer
- Hepatitis C Virus
- HIV
- Natural History
- Hemophilia
- Hepatitis C
- Carcinoma
- Hemophilia A
- Lymphoma
- Lymphoma, Non-Hodgkin
- Liver Failure
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Childrens National Medical Center | Washington, District of Columbia |
| Wake Forest University | Winston-Salem, North Carolina 27103 |
| Children's Hospital of Orange County | Orange, California 92668 |
| University of Colorado | Denver, Colorado 80217 |
| University of Oklahoma | Oklahoma City, Oklahoma 73190 |
| University of Minnesota | Minneapolis, Minnesota 55455 |
| Wayne State University Hutzel Hospital | Detroit, Michigan 48201 |
| University of California, San Francisco | San Francisco, California 94143 |
| University of Utah | Salt Lake City, Utah |
| University of Arizona | Tucson, Arizona 85724 |
| Vanderbilt University | Nashville, Tennessee 37232-6305 |
| University of North Carolina | Chapel Hill, North Carolina 27599 |
| University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
| Georgetown University | Washington, District of Columbia 20007-2197 |
| Emory University | Atlanta, Georgia 30322 |
| Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
| Ohio State University | Columbus, Ohio 43210 |
| University of New Mexico | Albuquerque, New Mexico 87131 |
| St. Louis University | St. Louis, Missouri 63110 |
| Mt. Sinai Medical Center | New York, New York 10029 |
| University of Cincinnati | Cincinnati, Ohio 45267-0502 |
| Childrens Memorial Hospital, Chicago | Chicago, Illinois 60614 |
| Cornell University | New York, New York 10021 |
| Wright State University | Dayton, Ohio 45408 |
| University of Illinois | Chicago, Illinois 60612 |
| University of Tennessee | Memphis, Tennessee 38163 |
| Childrens Hospital of Wisconsin | Milwaukee, Wisconsin 53201 |
| University of California, Davis | Sacramento, California 95818 |
| Tulane University | New Orleans, Louisiana 70112-2699 |
| Milton Hershey Medical Center | Hershey, Pennsylvania 17033-2390 |
| University of Texas, Houston | Houston, Texas 77225 |
| University of Texas, San Antonio | San Antonio, Texas 78229-3900 |
| Christiana Hospital | Wilmington, Delaware |
| St. Vincent's Hospital | Indiannapolis, Indiana |
| University of Mississippi | Jackson, Mississippi 39216 |
| University of Buffalo | Buffalo, New York |
| North Shore Long Island Jewish Health System | Lake Success, New York 11042 |
| Childrens Hospital, Cinncinati | Cinncinati, Ohio 45229-3039 |
| Palmentto Health Alliance | Columbia, South Carolina 29202 |
