Hepatitis CNCT00005657
Genetics of Hepatitis C Virus Infection
An observational study of Hepatitis C and Liver Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Hepatitis C, Liver Disease
- How many people
- 870 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2000to 19 Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Immunogenetics of Hepatitis C Virus Infection
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.
Read the detailed description
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
- Medical subject headings
- Hepatitis C, Liver Diseases, Hepatitis C, Chronic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2000 (estimated)
- Study start4 May 2000
- Study completion19 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 870 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005657
- Sponsor's protocol ID
- 000125
- Other IDs
- 00-DK-0125
- Status last verified
- 19 Apr 2011
- First submitted
- 6 May 2000
- Last updated
- 2 Jul 2017
- Results posted
- No
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.
PubMed 2300741Hill 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.
PubMed 1865923Hill AV. The immunogenetics of human infectious diseases. Annu Rev Immunol. 1998;16:593-617. doi: 10.1146/annurev.immunol.16.1.593.
PubMed 9597143
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenetics of Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT00005657
- Acronym / sponsor ID
- 000125
- Conditions
- Hepatitis C, Liver Disease
- Keywords
- Cytokines, Treatment, Genetic Polymorphism, Chronic Hepatitis C, Mononuclear Cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 870 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 4 May 2000
- Study completion
- 19 Apr 2011
- First posted
- 8 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 2300741Todd 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.
- Background: PubMed 1865923Hill 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.
- Background: PubMed 9597143Hill AV. The immunogenetics of human infectious diseases. Annu Rev Immunol. 1998;16:593-617. doi: 10.1146/annurev.immunol.16.1.593.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Liver Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005657, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.