Hepatitis D Virus Infection Among Hepatitis B Virus Surface Antigen Positive Individuals

Completed

• Conditions: HBV Infection; HDV Infection

• Registration Number: NCT04038372
• Lead Sponsor: Assiut University

Brief Summary

Globally, about 248 million people are chronic HBV surface antigen carriers, and about 5% of them also had hepatitis delta virus (HDV) infection as well. The prevalence of HBsAg in Egypt is intermediate (2-7%) .

Hepatitis D virus (HDV) is an incomplete RNA virus that needs hepatitis B surface antigen (HBsAg) to help its replication. HDV is considered a subviral particle because it depends on HBV for its propagation. Combined HDV- HBV infection produces more severe liver affection than HBV alone.

HDV infection leads to both of acute and chronic liver illnesses. Acute HDV infection can occur at the same time with acute HBV infection (coinfection) or can be superimposed on the top of chronic HBV infection. About 20% to 30% of coinfections of HDV and HBV in humans develop fatal fulminant hepatitis versus 2% of patients with acute hepatitis B mono-infection. Worldwide, Hepatitis D virus (HDV) infection present in more than 15 million people and it is endemic in the Middle East . In Upper Egypt, data about the prevalence, clinical, laboratory and virological characters of Hepatitis D virus-infected patients is rare.

This study aims were:

1. To estimate the prevalence of hepatitis D virus infection among HBsAg positive individuals.

2. To determine the clinical, laboratory and virological characters of HDV infected patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Study First Submitted: 2019-01-13
• Status Verified: 2019-04
• Study First Submitted QC: 2019-07-27
• Last Update Submitted: 2019-07-27
• Study First Posted: 2019-07-30
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

• HBV related liver disorder, aged 18-60 years.
• HBsAg positive individuals were divided into different clinical categories according to EASL 2012 and we revised this classification according to EASL 2017. HBeAg negative chronic infection; HBeAg positive chronic infection), Acute hepatitis, Fulminant hepatitis, Chronic hepatitis (HBeAg positive and HBeAg negative), Liver cirrhosis, and Primary HCC.

Exclusion Criteria

• Dual infection with other viruses as HCV and/or HIV, auto-immune or alcoholic hepatitis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine Anti- HDV prevalence among HBsAg positive individuals.	2 years	The investigators measured Anti HDV(total) in HBsAg positive cases. Qualitative anti-HDV determination is a competitive assay, based on the ELISA technique (Enzyme-LinkedImmunosorbent), using the methodology described in the man-ufacturer's protocol. ETI-AB-DELTAK-2 (P2808) (Diasorine SPA) Italy.
To determine the prevalence of hepatitis D virus active infection.	2 years	The investigators did qualitative measurement of HDV PCR in Anti - HDV positive cases. Real time PCR for HDV RNA was done.