Clinical trial NCT04593355: HCV Epidemiological Survey in China Rural Area
Official title: HCV Epidemiological Survey of Chinese in Northeast Rural Area Which Have Injection History
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis
Keywords: Predict
Hepatitis C Virus
Metabolomics
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Sciences
First posted: 2020-10-20
Enrollment: 6068
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Anti-HCV
timeFrame: Baseline
Secondary outcomes:
measure: Alanine Aminotransferase (ALT) and Aspartate transaminase (AST)
timeFrame: Baseline
measure: Fibrosis stage
timeFrame: Baseline
measure: Regular blood test
timeFrame: Baseline
measure: Blood HCV RNA Copies
timeFrame: Baseline
measure: HCV genotype
timeFrame: Baseline
measure: Drug abuse history
timeFrame: Baseline
measure: Alcohol ,smoking condition
timeFrame: Baseline
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Junqi Niu, PhD/MD
role: STUDY_CHAIR
References: