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

NCT05394623 | Unknown

• 1 other identifier: 2021-8764
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• HDV seroprevalence and HDV RNA prevalence amongst HBsAg positive carriers in China.

  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).

  3 months

Secondary Outcomes (1)

• The distribution of HDV genotypes in China

  3 months

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hepatitis D virus-infected patients in HBsAg positive population from 10 hospitals located in 5 diſferent geographical areas (North, South, East, West and Central) in China.

You may qualify if:

• Positive HBV surface antigen (HBsAg)
• Age 18 yeas and above

You may not qualify if:

• \. Severe cardiac, renal, respiratory, hematological, or psychiatric illness.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Gilead Sciences: collaborator

MeSH Terms

Conditions

Hepatitis D; Hepatitis B; RNA Virus Infections

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: November 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-11