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The Second Multicenter Hemophilia Cohort Study

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ClinicalTrials.gov Identifier: NCT00341705
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : June 20, 2018
Sponsor:
Collaborator:
Multicenter Hemophilia Cohort Study
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Description
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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.

Condition or disease
Liver Decompensation Hepatocellular Carcinoma Non-Hodgkin Lymphoma

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.

Study Design
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Study Type : Observational
Actual Enrollment : 2565 participants
Official Title: The Second Multicenter Hemophilia Cohort Study
Study Start Date : April 27, 2001
Study Completion Date : April 2, 2013

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00341705


  Show 48 Study Locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Multicenter Hemophilia Cohort Study
Investigators
Principal Investigator: James J Goedert, M.D. National Cancer Institute (NCI)
More Information
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Publications:

ClinicalTrials.gov Identifier: NCT00341705     History of Changes
Other Study ID Numbers: 999901170
01-C-N170
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: April 2, 2013

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