Prevalence and Burden of Hepatitis D Virus Infection in China Through Preoperative Examination Test (Predict Study)

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05394623

Collaborator

Gilead Sciences (Industry)

5,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

In China, there is no recommendation for Hepatitis D virus (HDV) screening, but the fact is estimated that one-third of the world's population of individuals with chronic Hepatitis B virus (HBV) infection live in China while we do not know the prevalence of co-infection of HBV/HDV in China. So far, no nationwide study has been undertaken to evaluate the epidemiology of hepatitis D, on the other hand, reports of HDV infection rate in different regions of China are not consistent because of the different detection methods and detection objects. Here, we plan to test HDV-Ab/RNA for 5000 HBsAg reactive samples from 10 major tertiary hospital and to know the prevalence and disease burden of HDV in China.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis D Hepatitis B Antibodies; Anti-D RNA Virus Infections	Diagnostic Test: HDV-Ab (IgG), HDV-RNA, RNA genotype

Study Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Prevalence and Burden of Hepatitis D Virus Infection in China Through Preoperative Examination Test (Predict Study)

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Outcome Measures

Primary Outcome Measures

HDV seroprevalence and HDV RNA prevalence amongst HBsAg positive carriers in China. [3 months]
Briefly, serum samples were tested undiluted, and after dilution of 1:10, 1:100, 1:1,000, 1:5,000, 1:10,000, 1:50,000, and was considered the highest dilution with a S/Co value >1.0. The detection system consisted of a competitive enzyme immunoassay, in which Anti-HDV antibodies (IgG/IgM), if present in the sample, compete with a virus-specific human polyclonal IgG, labeled with peroxidase (HRP), for a ţxed amount of full-length rec-HDV coated on the microplate. Qualitative HDV RNA was determined by in-house Polymerase Chain Reaction (PCR). Quantitative HDV-RNA was performed by means of LightCycler 2.0 (lower limit of detection 10 copies/reaction).