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

NCT ID: NCT05394623

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis D Hepatitis B Antibodies; Anti-D RNA Virus Infections

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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HDV-Ab (IgG), HDV-RNA, RNA genotype

Anti-HDV was evaluated semiquantitatively by means of end-point dilutions. Quantitative HDV-RNA was performed by means of LightCycler 2.0. Genotyping of HDV was performed by direct sequencing of the delta antigen region.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Positive HBV surface antigen (HBsAg)
2. Age 18 yeas and above

Exclusion Criteria

1\. Severe cardiac, renal, respiratory, hematological, or psychiatric illness.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2021-8764

Identifier Type: -

Identifier Source: org_study_id

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