The Second Multicenter Hemophilia Cohort Study
- Conditions
- Liver DecompensationNon-Hodgkin LymphomaHepatocellular Carcinoma
- Registration Number
- NCT00341705
- Lead Sponsor
- National Cancer Institute (NCI)
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2565
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (48)
University of Illinois
🇺🇸Chicago, Illinois, United States
South East Health Care Corporation
🇨🇦New Brunswick, Canada
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Childrens Memorial Hospital, Chicago
🇺🇸Chicago, Illinois, United States
Emory University
🇺🇸Atlanta, Georgia, United States
St. Vincent's Hospital
🇺🇸Indianapolis, Indiana, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
St. Louis University
🇺🇸Saint Louis, Missouri, United States
University of Buffalo
🇺🇸Buffalo, New York, United States
North Shore Long Island Jewish Health System
🇺🇸Lake Success, New York, United States
Cornell University
🇺🇸New York, New York, United States
Mt. Sinai Medical Center
🇺🇸New York, New York, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Wright State University
🇺🇸Dayton, Ohio, United States
Milton Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Palmentto Health Alliance
🇺🇸Columbia, South Carolina, United States
University of Tennessee
🇺🇸Memphis, Tennessee, United States
Hospital Brigadeiro
🇧🇷Sao Paulo, Brazil
University of Sao Paulo
🇧🇷Sao Paulo, Brazil
Karolinska Institute St. Gorans Hospital
🇸🇪Stockholm, Sweden
Christiana Hospital
🇺🇸Wilmington, Delaware, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Laikon General Hospital of Athens
🇬🇷Athens, Greece
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
University of California, Davis
🇺🇸Davis, California, United States
Childrens National Medical Center
🇺🇸Washington, District of Columbia, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Hospices Civils de Lyon
🇫🇷Lyons, France
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
University of Bonn
🇩🇪Bonn, Germany
University of Mississippi
🇺🇸Jackson, Mississippi, United States
University of Florence
🇮🇹Florence, Italy
University de Milano
🇮🇹Milan, Italy
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Colorado
🇺🇸Denver, Colorado, United States
Wayne State University Hutzel Hospital
🇺🇸Detroit, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Childrens Hospital, Cinncinati
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
University of Texas, Houston
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Childrens Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Texas, San Antonio
🇺🇸San Antonio, Texas, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States