Genetics of Hepatitis C Virus Infection

NCT00005657 | Completed

• 2 other identifiers: 00012500-DK-0125
• Study Type: observational
• Target: 870
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C; Liver Disease

Keywords

Cytokines; Treatment; Genetic Polymorphism; Chronic Hepatitis C; Mononuclear Cells

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Todd JR, West BC, McDonald JC. Human leukocyte antigen and leprosy: study in northern Louisiana and review. Rev Infect Dis. 1990 Jan-Feb;12(1):63-74. doi: 10.1093/clinids/12.1.63.

  PMID: 2300741 BACKGROUND

• Hill AV, Allsopp CE, Kwiatkowski D, Anstey NM, Twumasi P, Rowe PA, Bennett S, Brewster D, McMichael AJ, Greenwood BM. Common west African HLA antigens are associated with protection from severe malaria. Nature. 1991 Aug 15;352(6336):595-600. doi: 10.1038/352595a0.

  PMID: 1865923 BACKGROUND

• Hill AV. The immunogenetics of human infectious diseases. Annu Rev Immunol. 1998;16:593-617. doi: 10.1146/annurev.immunol.16.1.593.

  PMID: 9597143 BACKGROUND

MeSH Terms

Conditions

Hepatitis C; Liver Diseases; Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 6, 2000
• First Posted: May 8, 2000
• Study Start: May 4, 2000
• Study Completion: April 19, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-04-19

Locations

US (1)