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Completed

NCT Number: NCT04593355

HCV Epidemiological Survey in China Rural Area

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

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Hospital Jilin University

Changchun, Jilin, 130061, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Blood Anti-HCV

    Time frame: Baseline

    Co-infection status are analyzed.

Secondary outcomes

  1. Alanine Aminotransferase (ALT) and Aspartate transaminase (AST)

    Time frame: Baseline

    ALT AST are assayed to detect the hepatic function.

  2. Fibrosis stage

    Time frame: Baseline

    Fibrosis is analyzed with Fibroscan.

  3. Regular blood test

    Time frame: Baseline

    The distribution and absolute count of the different types of blood cells are assayed.

  4. Blood HCV RNA Copies

    Time frame: Baseline

    Blood HCV RNA copies were assayed with Roche - COBAS® AmpliPrep/COBAS® TaqMan® HCV Test.

  5. HCV genotype

    Time frame: Baseline

    HCV NS5A is cloned into T vector and sequenced for evolutionary analysis.

  6. Drug abuse history

    Time frame: Baseline

    Patients will be asked about their drug usage history.

  7. Alcohol ,smoking condition

    Time frame: Baseline

    Patients are asked whether they take alcohol or smoke cigarettes during the therapy period.

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Collaborators

  • Chinese Academy of Sciences

Registry information

Official study title

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

Acronym: HCVES

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 20, 2020
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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