Hepatitis D Virus Infection Among Hepatitis B Virus Surface Antigen Positive Individuals
|ClinicalTrials.gov Identifier: NCT04038372|
Recruitment Status : Completed
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
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:
- To estimate the prevalence of hepatitis D virus infection among HBsAg positive individuals.
- To determine the clinical, laboratory and virological characters of HDV infected patients.
|Condition or disease|
|HDV Infection HBV Infection|
|Study Type :||Observational|
|Actual Enrollment :||186 participants|
|Official Title:||Hepatitis D Virus Infection Among Hepatitis B Virus Surface Antigen Positive Individuals in Upper Egypt: Prevalence and Clinical Features|
|Actual Study Start Date :||November 2015|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038372
|Study Director:||Amal A Mahmoud, MD, Assistanr Professor||Assiut University|