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

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.

Study Overview

• Status: Completed
• Conditions: Observe and Describe the Prevalence of Hepatitis D Infection Among HBsAg Positive People

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 Type: Observational
• Enrollment (Actual): 5000

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Hepatitis B surface antigen or HBV DNA positive

Description

Inclusion Criteria:

• Hepatitis B surface antigen or HBV DNA positive

Exclusion Criteria:

• Can't sign informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
HBV patients; HBV patients with HBsAg positive and/or HBV DNA positive

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University
• Collaborators: Nanfang Hospital of Southern Medical University; Ruijin Hospital; Shandong Provincial Hospital; The Fourth Affiliated Hospital of Harbin Medical University
• Investigators: Study Director: Junqi Niu, Dr., The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): July 7, 2020
• Study Completion (Actual): July 7, 2020

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: HBV DNA; HBsAg positive
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Infections; Communicable Diseases; Hepatitis; Hepatitis A; Virus Diseases; Hepatitis D
• Other Study ID Numbers: 19K056-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Infection rate data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No