Protocol Number: 00-DK-0125

Title:

Immunogenetics of Hepatitis C Virus Infection

Number:

00-DK-0125

Summary:

The course of hepatitis C varies among people infected with the virus. Some people respond to treatment while many do not; some recover completely while others remain chronically infected; and among those who remain infected, some have mild symptoms while others' symptoms are severe. This study will look for genetic factors that may contribute to these differences.

Children over 2 years of age and adults with hepatitis C virus infection or with other kinds of liver disease (such as hepatitis B virus infection, primary biliary cirrhosis, Wilson's disease and others), and normal volunteers may be eligible for this study.

Participants will provide 40 to 60 centiliters (1 to 2 ounces) of blood. DNA will be isolated from the white blood cells for analysis of genes involved in certain immune functions. The genetic findings from patients with hepatitis C, patients with other forms of liver disease, and normal volunteers will be compared to try to learn how the differences may influence the symptoms and course of hepatitis C and to understand how the virus causes disease.

The results of this study may provide information useful for developing a vaccine and better treatments for hepatitis C.

Sponsoring Institute:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Patients who have recovered from past HCV exposure (positive anti-HCV but negative HCV viremia and absent liver disease).

Patients with asymptomatic HCV infection (positive anti-HCV and HCV viremia, but persistently normal or minimally elevated ALT and normal or mild disease on liver biopsy).

Patients with active liver disease (positive anti-HCV and HCV viremia, persistently elevated ALT and/or moderate disease on liver biopsy).

Patients with active extrahepatic manifestations of HCV infection (cryoglobulinemia, glomerulonephritis, vasculitis, etc.).

Patients with rapidly progressive, severe liver disease and/or hepatocellular carcinoma.

Patients who have undergone or are undergoing treatment.

Patients from a single-source outbreak of HCV infections (in which the viral factors should be identical and the patients are often from a homogeneous population with less genetic variability).

HCV infected family members and twins.

Patients with other forms of liver disease including HBV infection, primary biliary cirrhosis, autoimmune hepatitis, nonalcoholic steatohepatitis, hemochromatosis, and Wilson's Disease, as well as normal volunteers.

EXCLUSION CRITERIA:

Adult subjects with a Hct of less than 30 or pediatric subjects less than 25 will be excluded.

Children with HCV infection younger than 2 years of age will be excluded.

Unaffected healthy volunteers who are minors are not eligible for this study.

Special Instructions: Currently Not Provided

Keywords:

Cytokines

Treatment

Genetic Polymorphism

Chronic Hepatitis C

Mononuclear Cells

Recruitment Keywords:

None

Conditions:

Hepatitis C

Liver Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Human leukocyte antigen and leprosy: study in northern Louisiana and review

Common west African HLA antigens are associated with protection from severe malaria

The immunogenetics of human infectious diseases

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/23/2004