The Second Multicenter Hemophilia Cohort Study - Full Text View

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:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: HIV/AIDS

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Hemophilia Hemophilia A Liver Cancer

U.S. FDA Resources

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 (Child, Adult, Senior)
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

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

Publications:

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

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.

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.


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:


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

ClinicalTrials.gov processed this record on September 30, 2016