The Second Multicenter Hemophilia Cohort Study
2 other identifiers
observational
2,565
8 countries
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2001
Longer than P75 for all trials
48 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 27, 2001
CompletedFirst Submitted
Initial submission to the registry
June 19, 2006
CompletedFirst Posted
Study publicly available on registry
June 21, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2013
CompletedDecember 17, 2019
April 2, 2013
June 19, 2006
December 14, 2019
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
University of Arizona
Tucson, Arizona, 85724, United States
University of California, Davis
Davis, California, 95616, United States
Children's Hospital of Orange County
Orange, California, 92613, United States
University of California, San Francisco
San Francisco, California, 94143, United States
University of Colorado
Denver, Colorado, 80220-3706, United States
Christiana Hospital
Wilmington, Delaware, United States
Georgetown University
Washington D.C., District of Columbia, 20007-2197, United States
Childrens National Medical Center
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, 30322-1102, United States
University of Illinois
Chicago, Illinois, 60612, United States
Childrens Memorial Hospital, Chicago
Chicago, Illinois, 60614-3394, United States
St. Vincent's Hospital
Indianapolis, Indiana, United States
Tulane University
New Orleans, Louisiana, 70112-2699, United States
Wayne State University Hutzel Hospital
Detroit, Michigan, 48201, United States
University of Minnesota
Minneapolis, Minnesota, 55415, United States
University of Mississippi
Jackson, Mississippi, 39216, United States
St. Louis University
St Louis, Missouri, 63104, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
University of Buffalo
Buffalo, New York, United States
North Shore Long Island Jewish Health System
Lake Success, New York, 11042, United States
Cornell University
New York, New York, 10021-4872, United States
Mt. Sinai Medical Center
New York, New York, 10029-0574, United States
University of North Carolina
Chapel Hill, North Carolina, 27599-7030, United States
Wake Forest University
Winston-Salem, North Carolina, 27103, United States
Childrens Hospital, Cinncinati
Cincinnati, Ohio, 45229-3039, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Ohio State University
Columbus, Ohio, 43210-1240, United States
Wright State University
Dayton, Ohio, 45435, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Milton Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6056, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107-6541, United States
Palmentto Health Alliance
Columbia, South Carolina, 29202, United States
University of Tennessee
Memphis, Tennessee, 38103, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
University of Texas, Houston
Houston, Texas, 77030, United States
University of Texas, San Antonio
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Brigadeiro
São Paulo, Brazil
University of Sao Paulo
São Paulo, Brazil
South East Health Care Corporation
New Brunswick, Canada
Hospices Civils de Lyon
Lyon, France
University of Bonn
Bonn, Germany
Laikon General Hospital of Athens
Athens, Greece
University of Florence
Florence, Italy
University de Milano
Milan, Italy
Karolinska Institute St. Gorans Hospital
Stockholm, Sweden
Related Publications (3)
Mannucci PM, Tuddenbam EG. The hemophilias: progress and problems. Semin Hematol. 1999 Oct;36(4 Suppl 7):104-17.
PMID: 10595759BACKGROUNDKroner BL, Rosenberg PS, Aledort LM, Alvord WG, Goedert JJ. HIV-1 infection incidence among persons with hemophilia in the United States and western Europe, 1978-1990. Multicenter Hemophilia Cohort Study. J Acquir Immune Defic Syndr (1988). 1994 Mar;7(3):279-86.
PMID: 8106967BACKGROUNDEyster ME, Diamondstone LS, Lien JM, Ehmann WC, Quan S, Goedert JJ. Natural history of hepatitis C virus infection in multitransfused hemophiliacs: effect of coinfection with human immunodeficiency virus. The Multicenter Hemophilia Cohort Study. J Acquir Immune Defic Syndr (1988). 1993 Jun;6(6):602-10.
PMID: 8098752BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James J Goedert, M.D.
National Cancer Institute (NCI)