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CompletedNCT04593355HCVESUpdated Oct 20, 2020

HCV Epidemiological Survey in China Rural Area

An observational study in Hepatitis, sponsored by The First Hospital of Jilin University. Completed at 1 site in China. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-10-20.

Sponsored by The First Hospital of Jilin University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,068
Ages
20 Years to 85 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Hepatitis

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Keywords

  • Predict
  • Hepatitis C Virus
  • Metabolomics
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In context

Hepatitis

3,381 studies on the registry are indexed under Hepatitis; 202 are open to participants now.

This study's enrollment of 6,068 is above the median of 253 across 823 observational studies indexed under Hepatitis.

Browse Hepatitis studies →

Lead sponsor

The First Hospital of Jilin University is the lead sponsor of 181 studies on the registry; 93 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients are from the northeast of China. Most of the patients have been infected by the hepatitis c virus due to the drug abuse. Many of them share the same syringe for drug intravenous injection. However, HIV infection has been rarely detected.

Inclusion criteria

  • aged from 20 to 65

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6,068 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • HCV
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What researchers measure

Primary outcomes

  1. Blood Anti-HCV

    Co-infection status are analyzed.

    Time frame: Baseline

Secondary outcomes

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

    ALT AST are assayed to detect the hepatic function.

    Time frame: Baseline

  2. Fibrosis stage

    Fibrosis is analyzed with Fibroscan.

    Time frame: Baseline

  3. Regular blood test

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

    Time frame: Baseline

  4. Blood HCV RNA Copies

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

    Time frame: Baseline

  5. HCV genotype

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

    Time frame: Baseline

  6. Drug abuse history

    Patients will be asked about their drug usage history.

    Time frame: Baseline

  7. Alcohol ,smoking condition

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

    Time frame: Baseline

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Study locations

1 site
  • First Hospital Jilin University
    Changchun, Jilin 130061, China
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04593355
Lead sponsor
The First Hospital of Jilin University
Collaborators
Chinese Academy of Sciences
Responsible party
Junqi Niu (Vice-President of First Hospital of Jilin University, The First Hospital of Jilin University) — Principal investigator
First posted
Oct 20, 2020
Start date
Dec 2009
Primary completion
Sep 2012
Completion
Sep 2012
Last update
Oct 20, 2020

Study contacts

Junqi Niu, PhD/MD
study chair · The First Hospital of Jilin University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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