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HCV Epidemiological Survey in China Rural Area

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04593355
Acronym
HCVES
Enrollment
6068
Registered
2020-10-20
Start date
2009-12-31
Completion date
2012-09-30
Last updated
2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis

Keywords

Predict, Hepatitis C Virus, Metabolomics

Brief summary

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

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.

Interventions

None listed

Sponsors

Chinese Academy of Sciences
CollaboratorOTHER_GOV
The First Hospital of Jilin University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood Anti-HCVBaselineCo-infection status are analyzed.

Secondary

MeasureTime frameDescription
Fibrosis stageBaselineFibrosis is analyzed with Fibroscan.
Regular blood testBaselineThe distribution and absolute count of the different types of blood cells are assayed.
Blood HCV RNA CopiesBaselineBlood HCV RNA copies were assayed with Roche - COBAS® AmpliPrep/COBAS® TaqMan® HCV Test.
Alanine Aminotransferase (ALT) and Aspartate transaminase (AST)BaselineALT AST are assayed to detect the hepatic function.
Drug abuse historyBaselinePatients will be asked about their drug usage history.
Alcohol ,smoking conditionBaselinePatients are asked whether they take alcohol or smoke cigarettes during the therapy period.
HCV genotypeBaselineHCV NS5A is cloned into T vector and sequenced for evolutionary analysis.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026