the first hospital of Jilin University
Changchun, Jilin, 130021, China
Completed
NCT Number: NCT04483518
Epidemiological Survey of Hepatitis D Virus Infection in China
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.
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Age range
16 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Hepatitis B surface antigen or HBV DNA positive
Exclusion criteria
- Can't sign informed consent
Treatment and study plan
Primary outcomes
-
The prevalence of hepatitis D virus
Time frame: 2019-2020
Proportion of hepatitis D infection in people with hepatitis B infection
Sponsors and collaborators
Lead sponsor
The First Hospital of Jilin University
Other
Collaborators
- Nanfang Hospital, Southern Medical University
- Ruijin Hospital
- Shandong Provincial Hospital
- The Fourth Affiliated Hospital of Harbin Medical University
Registry information
Official study title
Epidemiological Survey of Hepatitis D Virus Infection in Hepatitis B Population Among Multi-center Hepatitis B Population in China
Important dates
- Study start
- 2019
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Jul 23, 2020
- Registry last updated
- Jul 23, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.