HCV Epidemiological Survey in China Rural Area

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the morbidity of hepatitis C with Chinese population.

Detailed Description
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Hepatitis C virus (HCV) infection rate in China is about 3%, which means about 30 million patients. More importantly, many of those patients with chronic hepatitis C eventually develop cirrhosis and hepatocellular carcinoma(HCC).Our survey found the rate of hepatitis c infection in northeastern China without intervention is 34.3%, due to the abuse of caffeine sodium benzoate. This population has the similar mode of transmission, which is a fine study of the natural outcome hepatitis C. We plan to carry out epidemiological studies for this population, review of the influencing factors of the disease, and analyze the host factors that can effect the prognosis.

Official Title
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HCV Epidemiological Survey of Chinese in Northeast Rural Area Which Have Injection History

Conditions
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Hepatitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged from 20 to 65 Exclusion Criteria: Has history of decompensated liver diseases Has been treated with other anti-virus drugs,or anti-tumor drugs,immuno-suppression drugs Has a history of autoimmune hepatitis History of a severe seizure disorder or current anticonvulsant use History or other evidence of a medical condition associated with chronic liver disease other than HCV which would make the patient, in the opinion of the investigator, unsuitable for the study (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures) Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4g/dL (as may be seen with ribavirin therapy) would not be well-tolerated History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCV<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Anti-HCV | Co-infection status are analyzed. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alanine Aminotransferase (ALT) and Aspartate transaminase (AST) | ALT AST are assayed to detect the hepatic function. | Baseline | 
| Fibrosis stage | Fibrosis is analyzed with Fibroscan. | Baseline | 
| Regular blood test | The distribution and absolute count of the different types of blood cells are assayed. | Baseline | 
| Blood HCV RNA Copies | Blood HCV RNA copies were assayed with Roche - COBAS® AmpliPrep/COBAS® TaqMan® HCV Test. | Baseline | 
| HCV genotype | HCV NS5A is cloned into T vector and sequenced for evolutionary analysis. | Baseline | 
| Drug abuse history | Patients will be asked about their drug usage history. | Baseline | 
| Alcohol ,smoking condition | Patients are asked whether they take alcohol or smoke cigarettes during the therapy period. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Predict, Hepatitis C Virus, Metabolomics