The Second Multicenter Hemophilia Cohort Study

This study has been completed.
Sponsor:
Collaborator:
Multicenter Hemophilia Cohort Study
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00341705
First received: June 19, 2006
Last updated: February 19, 2014
Last verified: April 2013
  Purpose

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.


Condition
Liver Decompensation
Hepatocellular Carcinoma
Non-Hodgkin Lymphoma

Study Type: Observational
Official Title: The Second Multicenter Hemophilia Cohort Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 5000
Study Start Date: April 2001
Estimated Study Completion Date: April 2013
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00341705

  Hide Study Locations
Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
University of California, Davis
Davis, California, United States, 95616
Children's Hospital of Orange County
Orange, California, United States, 92613
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80220-3706
United States, Delaware
Christiana Hospital
Wilmington, Delaware, United States
United States, District of Columbia
Childrens National Medical Center
Washington, District of Columbia, United States
Georgetown University
Washington, District of Columbia, United States, 20007-2197
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322-1102
United States, Illinois
University of Illinois
Chicago, Illinois, United States, 60612
Childrens Memorial Hospital, Chicago
Chicago, Illinois, United States, 60614-3394
United States, Indiana
St. Vincent's Hospital
Indiannapolis, Indiana, United States
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112-2699
United States, Michigan
Wayne State University Hutzel Hospital
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55415
United States, Mississippi
University of Mississippi
Jackson, Mississippi, United States, 39216
United States, Missouri
St. Louis University
St. Louis, Missouri, United States, 63104
United States, New Mexico
University of New Mexico
Alburquerque, New Mexico, United States, 87131
United States, New York
University of Buffalo
Buffalo, New York, United States
North Shore Long Island Jewish Health System
Lake Success, New York, United States, 11042
Cornell University
New York, New York, United States, 10021-4872
Mt. Sinai Medical Center
New York, New York, United States, 10029-0574
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7030
Wake Forest University
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Childrens Hospital, Cinncinati
Cinncinati, Ohio, United States, 45229-3039
Ohio State University
Columbus, Ohio, United States, 43210-1240
Wright State University
Dayton, Ohio, United States, 45435
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Milton Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6056
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107-6541
United States, South Carolina
Palmentto Health Alliance
Columbia, South Carolina, United States, 29202
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38103
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas, Houston
Houston, Texas, United States, 77030
University of Texas, San Antonio
San Antonio, Texas, United States
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Brazil
University of Sao Paulo
Sao Paulo, Brazil
Hospital Brigadeiro
Sao Paulo, Brazil
Canada
South East Health Care Corporation
New Brunswick, Canada
France
Hospices Civils de Lyon
Lyons, France
Germany
University of Bonn
Bonn, Germany
Greece
Laikon General Hospital of Athens
Athens, Greece
Italy
University of Florence
Florence, Italy
University de Milano
Milan, Italy
Sweden
Karolinska Institute St. Gorans Hospital
Stockholm, Sweden
Sponsors and Collaborators
Multicenter Hemophilia Cohort Study
Investigators
Principal Investigator: James J Goedert, M.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00341705     History of Changes
Other Study ID Numbers: 999901170, 01-C-N170
Study First Received: June 19, 2006
Last Updated: February 19, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
AIDS
Cancer
Hepatitis C Virus
HIV
Natural History
Hemophilia
Hepatitis C

Additional relevant MeSH terms:
Carcinoma
Hemophilia A
Lymphoma
Lymphoma, Non-Hodgkin
Liver Failure
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on August 27, 2014