Epidemiological Survey of Hepatitis D Virus Infection in China

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04483518
• Other study ID #: 19K056-001
• Status: Completed
• Start date: June 3, 2019
• Est. completion date: July 7, 2020

Study information

• Verified date: July 2020
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: July 7, 2020
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Hepatitis B surface antigen or HBV DNA positive

Exclusion Criteria:

• Can't sign informed consent

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis D
• Infection
• Observe and Describe the Prevalence of Hepatitis D Infection Among HBsAg Positive People
• Virus Diseases

Locations

Country	Name	City	State
China	the first hospital of Jilin University	Changchun	Jilin

Sponsors (5)

Lead Sponsor	Collaborator
First Hospital of Jilin University	Nanfang Hospital of Southern Medical University, Ruijin Hospital, Shandong Provincial Hospital, The Fourth Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

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