Epidemiological Survey of Hepatitis D Virus Infection in China

Epidemiological Survey of Hepatitis D Virus Infection in Hepatitis B Population Among Multi-center Hepatitis B Population in China

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04483518

Enrollment

5000

Registered

2020-07-23

Start date

2019-06-03

Completion date

2020-07-07

Last updated

2020-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Observe and Describe the Prevalence of Hepatitis D Infection Among HBsAg Positive People

Keywords

HBsAg positive, HBV DNA

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Hepatitis B surface antigen or HBV DNA positive

Exclusion criteria

* Can't sign informed consent

Design outcomes

Primary

Measure	Time frame	Description
The prevalence of hepatitis D virus	2019-2020	Proportion of hepatitis D infection in people with hepatitis B infection

Countries

China

Outcome results