HDV InfectionNCT04038372
Hepatitis D Virus Infection Among Hepatitis B Virus Surface Antigen Positive Individuals
An observational study of HDV Infection and HBV Infection, run by Assiut University.
Trial 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%) . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HDV Infection, HBV Infection
- How many people
- 186 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Dual infection with other viruses as HCV and/or HIV, auto-immune or alcoholic hepatitis.
About this study
Official title: Hepatitis D Virus Infection Among Hepatitis B Virus Surface Antigen Positive Individuals in Upper Egypt: Prevalence and Clinical Features
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.
Read more
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.
- Conditions
- HDV Infection, HBV Infection
- Keywords
- HDV, HBsAg, prevalence, Upper Egypt
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine Anti- HDV prevalence among HBsAg positive individuals.
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.
Measured: 2 years
To determine the prevalence of hepatitis D virus active infection.
The investigators did qualitative measurement of HDV PCR in Anti - HDV positive cases. Real time PCR for HDV RNA was done.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study startNov 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HDV InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nahed A. Makhlouf, Assiut University
- Investigators
- Amal A Mahmoud, MD, Assistanr Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038372
- Sponsor's protocol ID
- HDVIAHBPI
- Status last verified
- Apr 2019
- First submitted
- 13 Jan 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis D Virus Infection Among Hepatitis B Virus Surface Antigen Positive Individuals in Upper Egypt: Prevalence and Clinical Features
- ClinicalTrials.gov ID
- NCT04038372
- Acronym / sponsor ID
- HDVIAHBPI
- Conditions
- HDV Infection, HBV Infection
- Keywords
- HDV, HBsAg, prevalence, Upper Egypt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Dual infection with other viruses as HCV and/or HIV, auto-immune or alcoholic hepatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal A Mahmoud, MD, Assistanr Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of HDV Infection and HBV Infection, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine Anti- HDV prevalence among HBsAg positive individuals. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.