HCV Epidemiological Survey in China Rural Area

Completed

• Conditions: Hepatitis

• Registration Number: NCT04593355
• Lead Sponsor: The First Hospital of Jilin University

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.

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2020-10
• Study First Submitted: 2020-10-13
• Study First Submitted QC: 2020-10-13
• Last Update Submitted: 2020-10-13
• Study First Posted: 2020-10-20
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6068

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood Anti-HCV	Baseline	Co-infection status are analyzed.

Secondary Outcome Measures

Name	Time	Method
HCV genotype	Baseline	HCV NS5A is cloned into T vector and sequenced for evolutionary analysis.
Fibrosis stage	Baseline	Fibrosis is analyzed with Fibroscan.
Alcohol ,smoking condition	Baseline	Patients are asked whether they take alcohol or smoke cigarettes during the therapy period.
Blood HCV RNA Copies	Baseline	Blood HCV RNA copies were assayed with Roche - COBAS® AmpliPrep/COBAS® TaqMan® HCV Test.
Alanine Aminotransferase (ALT) and Aspartate transaminase (AST)	Baseline	ALT AST are assayed to detect the hepatic function.
Regular blood test	Baseline	The distribution and absolute count of the different types of blood cells are assayed.
Drug abuse history	Baseline	Patients will be asked about their drug usage history.

Trial Locations

Locations (1)

First Hospital Jilin University; 🇨🇳 Changchun, Jilin, China