Epidemiological Survey of Hepatitis D Virus Infection in Hepatitis B Population Among Multi-center Hepatitis B Population in China
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 5,000
- Locations
- 1
- Primary Endpoint
- The prevalence of hepatitis D virus
Overview
Brief Summary
This cross-sectional study will screen out hepatitis D virus-infected patients in HBsAg-positive people. Observe and describe the prevalence of hepatitis D infection among HBsAg positive people. The provinces of China are divided into 5 geographical areas (North, South, East, West and Central) to recruit patients according to the population density of each area. After statistical calculation, the total number of population needed is 3808.
Detailed Description
Entry criteria：1. Age 18 years and above. 2. male or female. 3. Diagnosed as chronic HBV infection (HBsAg positive) 4.Ability to sign informed consent.
Exclusion criteria：Patients who disagree to participate in the trial.
After the informed consent was signed, the quantitative data of the previous surface antigen or HBV DNA titer was collected during the return visit. 4 ml of venous blood was collected on the same day or the remaining serum from the surface antigen or hepatitis B quantitative test was collected for the detection of hepatitis D antibody and/or the quantitative detection of hepatitis D RNA.
After statistical analysis, calculate the hepatitis D infection status in China.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hepatitis B surface antigen or HBV DNA positive
Exclusion Criteria
- •Can't sign informed consent
Outcomes
Primary Outcomes
The prevalence of hepatitis D virus
Time Frame: 2019-2020
Proportion of hepatitis D infection in people with hepatitis B infection
Secondary Outcomes
No secondary outcomes reported
Investigators
Junqi Niu
Director of the department of Hepatology
The First Hospital of Jilin University