HCV Epidemiological Survey in China Rural Area

NCT04593355 | Completed DMC

• 1 other identifier: 20110101
• Study Type: observational
• Target: 6,068
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis

Keywords

Predict; Hepatitis C Virus; Metabolomics

Outcome Measures

Primary Outcomes (1)

• Blood Anti-HCV

  Co-infection status are analyzed.

  Baseline

Secondary Outcomes (7)

• Alanine Aminotransferase (ALT) and Aspartate transaminase (AST)

  Baseline

• Fibrosis stage

  Baseline

• Regular blood test

  Baseline

• Blood HCV RNA Copies

  Baseline

• HCV genotype

  Baseline

Study Arms (1)

HCV

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• aged from 20 to 65

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead
• Chinese Academy of Sciences: collaborator

Study Sites (1)

First Hospital Jilin University

Changchun, Jilin, 130061, China

Location

Related Links

• Hospital's homepage

Biospecimen

Retention: SAMPLES WITH DNA

Blood serum,Peripheral blood mononuclear cells (PBMC),Urine

MeSH Terms

Conditions

Hepatitis; Hepatitis C

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections

Study Officials

• Junqi Niu, PhD/MD

  The First Hospital of Jilin University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-President of First Hospital of Jilin University

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: December 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 20, 2020

Record last verified: 2020-10

Locations

CN (1)