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Completed

NCT Number: NCT04038372

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

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.

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Key information

Conditions

HDV Infection HBV Infection

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. To determine Anti- HDV prevalence among HBsAg positive individuals.

    Time frame: 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.

  2. To determine the prevalence of hepatitis D virus active infection.

    Time frame: 2 years

    The investigators did qualitative measurement of HDV PCR in Anti - HDV positive cases. Real time PCR for HDV RNA was done.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Hepatitis D Virus Infection Among Hepatitis B Virus Surface Antigen Positive Individuals in Upper Egypt: Prevalence and Clinical Features

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 30, 2019
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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