MedDataX Logo

The Second Multicenter Hemophilia Cohort Study

NCT ID: NCT00341705

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2565 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-04-27

Study Completion Date

2013-04-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Decompensation Hepatocellular Carcinoma Non-Hodgkin Lymphoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

AIDS Cancer Hepatitis C Virus HIV Natural History Hemophilia Hepatitis C

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Multicenter Hemophilia Cohort Study

UNKNOWN

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James J Goedert, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Arizona

Tucson, Arizona, United States

Site Status

University of California, Davis

Davis, California, United States

Site Status

Children's Hospital of Orange County

Orange, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

University of Colorado

Denver, Colorado, United States

Site Status

Christiana Hospital

Wilmington, Delaware, United States

Site Status

Georgetown University

Washington D.C., District of Columbia, United States

Site Status

Childrens National Medical Center

Washington D.C., District of Columbia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

University of Illinois

Chicago, Illinois, United States

Site Status

Childrens Memorial Hospital, Chicago

Chicago, Illinois, United States

Site Status

St. Vincent's Hospital

Indianapolis, Indiana, United States

Site Status

Tulane University

New Orleans, Louisiana, United States

Site Status

Wayne State University Hutzel Hospital

Detroit, Michigan, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

University of Mississippi

Jackson, Mississippi, United States

Site Status

St. Louis University

St Louis, Missouri, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

University of Buffalo

Buffalo, New York, United States

Site Status

North Shore Long Island Jewish Health System

Lake Success, New York, United States

Site Status

Cornell University

New York, New York, United States

Site Status

Mt. Sinai Medical Center

New York, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Childrens Hospital, Cinncinati

Cincinnati, Ohio, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Wright State University

Dayton, Ohio, United States

Site Status

University of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

Milton Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Palmentto Health Alliance

Columbia, South Carolina, United States

Site Status

University of Tennessee

Memphis, Tennessee, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

University of Texas, Houston

Houston, Texas, United States

Site Status

University of Texas, San Antonio

San Antonio, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Childrens Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Hospital Brigadeiro

São Paulo, , Brazil

Site Status

University of Sao Paulo

São Paulo, , Brazil

Site Status

South East Health Care Corporation

New Brunswick, , Canada

Site Status

Hospices Civils de Lyon

Lyon, , France

Site Status

University of Bonn

Bonn, , Germany

Site Status

Laikon General Hospital of Athens

Athens, , Greece

Site Status

University of Florence

Florence, , Italy

Site Status

University de Milano

Milan, , Italy

Site Status

Karolinska Institute St. Gorans Hospital

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Brazil Canada France Germany Greece Italy Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Mannucci PM, Tuddenbam EG. The hemophilias: progress and problems. Semin Hematol. 1999 Oct;36(4 Suppl 7):104-17.

Reference Type BACKGROUND
PMID: 10595759 (View on PubMed)

Kroner 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.

Reference Type BACKGROUND
PMID: 8106967 (View on PubMed)

Eyster 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.

Reference Type BACKGROUND
PMID: 8098752 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01-C-N170

Identifier Type: -

Identifier Source: secondary_id

999901170

Identifier Type: -

Identifier Source: org_study_id