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

June 19, 2006
February 19, 2014
April 2001
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Complete list of historical versions of study NCT00341705 on ClinicalTrials.gov Archive Site
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The Second Multicenter Hemophilia Cohort Study
The Second Multicenter Hemophilia Cohort Study

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.

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.

Observational
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  • Liver Decompensation
  • Hepatocellular Carcinoma
  • Non-Hodgkin Lymphoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5000
April 2013
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  • 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.

Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Canada,   France,   Germany,   Greece,   Italy,   Sweden
 
NCT00341705
999901170, 01-C-N170
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National Cancer Institute (NCI)
Multicenter Hemophilia Cohort Study
Principal Investigator: James J Goedert, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP