The Second Multicenter Hemophilia Cohort Study

Hepatocellular Carcinoma Clinical Trial

Official title:

The Second Multicenter Hemophilia Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00341705
• Other study ID #: 999901170
• Secondary ID: 01-C-N170
• Status: Completed
• Start date: April 27, 2001
• Est. completion date: April 2, 2013

Study information

• Verified date: April 2, 2013
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2565
• Est. completion date: April 2, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hemophilia A
• Hepatocellular Carcinoma
• Liver Decompensation
• Liver Failure
• Non-Hodgkin Lymphoma

Locations

Country	Name	City	State
Brazil	Hospital Brigadeiro	Sao Paulo
Brazil	University of Sao Paulo	Sao Paulo
Canada	South East Health Care Corporation	New Brunswick
France	Hospices Civils de Lyon	Lyons
Germany	University of Bonn	Bonn
Greece	Laikon General Hospital of Athens	Athens
Italy	University of Florence	Florence
Italy	University de Milano	Milan
Sweden	Karolinska Institute St. Gorans Hospital	Stockholm
United States	University of New Mexico	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	University of Buffalo	Buffalo	New York
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Childrens Memorial Hospital, Chicago	Chicago	Illinois
United States	University of Illinois	Chicago	Illinois
United States	Childrens Hospital, Cinncinati	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Palmentto Health Alliance	Columbia	South Carolina
United States	Ohio State University	Columbus	Ohio
United States	University of California, Davis	Davis	California
United States	Wright State University	Dayton	Ohio
United States	University of Colorado	Denver	Colorado
United States	Wayne State University Hutzel Hospital	Detroit	Michigan
United States	Milton Hershey Medical Center	Hershey	Pennsylvania
United States	University of Texas, Houston	Houston	Texas
United States	St. Vincent's Hospital	Indianapolis	Indiana
United States	University of Mississippi	Jackson	Mississippi
United States	North Shore Long Island Jewish Health System	Lake Success	New York
United States	University of Tennessee	Memphis	Tennessee
United States	Childrens Hospital of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt University	Nashville	Tennessee
United States	Tulane University	New Orleans	Louisiana
United States	Cornell University	New York	New York
United States	Mt. Sinai Medical Center	New York	New York
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Children's Hospital of Orange County	Orange	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	St. Louis University	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	University of Texas, San Antonio	San Antonio	Texas
United States	University of California, San Francisco	San Francisco	California
United States	University of Arizona	Tucson	Arizona
United States	Childrens National Medical Center	Washington	District of Columbia
United States	Georgetown University	Washington	District of Columbia
United States	Christiana Hospital	Wilmington	Delaware
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)	Multicenter Hemophilia Cohort Study

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  France,  Germany,  Greece,  Italy,  Sweden, 

References & Publications (3)

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. 1993 Jun;6(6):602-10. — View Citation

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. 1994 Mar;7(3):279-86. — View Citation

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