- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005657
Genetics of Hepatitis C Virus Infection
Immunogenetics of Hepatitis C Virus Infection
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- Hill AV. The immunogenetics of human infectious diseases. Annu Rev Immunol. 1998;16:593-617. doi: 10.1146/annurev.immunol.16.1.593.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000125
- 00-DK-0125
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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