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.

Condition
Hepatitis C Liver Disease

The diverse clinical syndromes associated with hepatitis C underscore the multifactorial and polygenic nature of HCV infection. Both viral and host factors likely contribute to variations in infection outcome, disease susceptibility and progression, and treatment response. This protocol will focus on the immunogenetics of HCV infection. Various candidate genes, most of them related to host immune response in microbial infection, have defined genetic polymorphisms that have been associated with variable manifestations of infections including malaria, tuberculosis, leprosy, AIDS and hepatitis B. In this proposal, we plan to collect peripheral blood mononuclear cells as a source of DNA from approximately 1500 patients with HCV infection, analyze genetic polymorphisms of various candidate genes in association with viral clearance, disease progression or treatment response, and characterize the functional consequences of these polymorphisms in patients with well-defined clinical sequelae of HCV infection. We will also collect blood from patients with other forms of liver diseases (approximately 300) or normal volunteers (approximately 200) as controls. By identifying relevant host factors genetically and investigating their molecular interactions with HCV, we may gain additional insights into HCV pathogenesis and uncover new potential targets for vaccine development and treatment intervention.

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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.

Maryland
      National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  000125; 00-DK-0125
Record last reviewed:  April 19, 2004
Last Updated:  April 19, 2004
Record first received:  May 6, 2000
ClinicalTrials.gov Identifier:  NCT00005657
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08