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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04038372
Recruitment Status : Completed
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Information provided by (Responsible Party):
Dr. Nahed A. Makhlouf, 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.

Condition or disease
HDV Infection HBV Infection

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Study Type : Observational
Actual Enrollment : 186 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study was a hospital-based, prospective, cross-sectional analytic one. The study was carried out on 186 HBsAg positive cases who were recruited from Tropical Medicine and Gastroenterology Department, Al Rajhi Liver Hospital, Assiut University, and Sohag University Hospital during two years.The Participants accepted to participate in the study.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04038372

Sponsors and Collaborators
Assiut University
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Study Director: Amal A Mahmoud, MD, Assistanr Professor Assiut University
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Responsible Party: Dr. Nahed A. Makhlouf, Principle Investigator, Assiut University Identifier: NCT04038372    
Other Study ID Numbers: HDVIAHBPI
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Nahed A. Makhlouf, Assiut University:
Upper Egypt
Additional relevant MeSH terms:
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Communicable Diseases
Hepatitis B
Virus Diseases
Hepatitis D
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections