HCVES: HCV Epidemiological Survey in China Rural Area
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether the morbidity of hepatitis C with Chinese population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HCV
|
Outcome Measures
Primary Outcome Measures
- Blood Anti-HCV [Baseline]
Co-infection status are analyzed.
Secondary Outcome Measures
- Alanine Aminotransferase (ALT) and Aspartate transaminase (AST) [Baseline]
ALT AST are assayed to detect the hepatic function.
- Fibrosis stage [Baseline]
Fibrosis is analyzed with Fibroscan.
- Regular blood test [Baseline]
The distribution and absolute count of the different types of blood cells are assayed.
- Blood HCV RNA Copies [Baseline]
Blood HCV RNA copies were assayed with Roche - COBAS® AmpliPrep/COBAS® TaqMan® HCV Test.
- HCV genotype [Baseline]
HCV NS5A is cloned into T vector and sequenced for evolutionary analysis.
- Drug abuse history [Baseline]
Patients will be asked about their drug usage history.
- Alcohol ,smoking condition [Baseline]
Patients are asked whether they take alcohol or smoke cigarettes during the therapy period.
Eligibility Criteria
Criteria
Inclusion Criteria:
- aged from 20 to 65
Exclusion Criteria:
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Has history of decompensated liver diseases
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Has been treated with other anti-virus drugs,or anti-tumor drugs,immuno-suppression drugs
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Has a history of autoimmune hepatitis
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History of a severe seizure disorder or current anticonvulsant use
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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)
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Hospital Jilin University | Changchun | Jilin | China | 130061 |
Sponsors and Collaborators
- The First Hospital of Jilin University
- Chinese Academy of Sciences
Investigators
- Study Chair: Junqi Niu, PhD/MD, The First Hospital of Jilin University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20110101