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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05394623
Other study ID # 2021-8764
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2022
Est. completion date July 1, 2023

Study information

Verified date November 2022
Source The First Affiliated Hospital with Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 5000
Est. completion date July 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
The First Affiliated Hospital with Nanjing Medical University Gilead Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary 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 txed 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 The distribution of HDV genotypes in China Genotyping of HDV was performed by direct sequencing of the delta antigen region. 3 months
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