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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.
 
ClinicalTrials.gov Identifier: NCT04038372
Recruitment Status : Completed
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Nahed A. Makhlouf, Assiut University

Tracking Information
First Submitted Date January 13, 2019
First Posted Date July 30, 2019
Last Update Posted Date July 30, 2019
Actual Study Start Date November 2015
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 27, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hepatitis D Virus Infection Among Hepatitis B Virus Surface Antigen Positive Individuals
Official Title Hepatitis D Virus Infection Among Hepatitis B Virus Surface Antigen Positive Individuals in Upper Egypt: Prevalence and Clinical Features
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • HDV Infection
  • HBV Infection
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 27, 2019)
186
Original Actual Enrollment Same as current
Actual Study Completion Date October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04038372
Other Study ID Numbers HDVIAHBPI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Dr. Nahed A. Makhlouf, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators
Study Director: Amal A Mahmoud, MD, Assistanr Professor Assiut University
PRS Account Assiut University
Verification Date April 2019