HCV Epidemiological Survey in China Rural Area

Hepatitis Clinical Trial

— HCVES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04593355
• Other study ID #: 20110101
• Status: Completed
• Start date: December 2009
• Est. completion date: September 2012

Study information

• Verified date: October 2020
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6068
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis

Locations

Country	Name	City	State
China	First Hospital Jilin University	Changchun	Jilin

Sponsors (2)

Lead Sponsor	Collaborator
First Hospital of Jilin University	Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

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

External Links

•   Cooperator's homepage
•   Hospital's homepage
•   The standard diagnosis and treatment protocol for HCV patients in China