HBV TransmissionNCT05523921
Intrafamilial Transmission of Hepatitis B Virus: Frequency, Risk Factors, and Role of Hepatitis B Vaccination
An observational study of HBV Transmission, run by Assiut University.
Trial summary
The primary aim of the study is to accomplish two major tasks: the first is to determine the frequency of intra-familial transmission of HBV; the second is trying to explore the potential risk factors of such a transmission .As a secondary aim, immunologic status of the household contacts vaccinated for hepatitis B… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HBV Transmission
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Oct 2023
- 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 80 years
- All sexes
- Adult, Older adult
Study population: We will provide clinical evaluation, laboratory investigations, and abdominal ultrasonography for every participant of the study. Clinical evaluation will include a detailed questionnaire concerning the potential risk factors of intra-familial transmission of HBV; it will include the kind of family relationship, demographic data, history of hepatitis B vaccination, and the potential routes of HBV transmission. The battery of laboratory work will include hepatitis B surface antigen (for diagnosis of infection), and titer of antibody to hepatitis B surface (for assessment of the immunologic status among non-infected subjects). In addition, liver chemistry panel will be performed for infected patients to help in the assessment of liver disease severity.
Who may be able to join
- : The household contacts of patients with chronic HBV infection will be included in the study.
Who cannot join
- Those with prior diagnosis of HBV infection following the date of the primary case infection.
Trial locations and contacts
No sites are listed yet.
About this study
The primary aim of the study is to accomplish two major tasks: the first is to determine the frequency of intra-familial transmission of HBV; the second is trying to explore the potential risk factors of such a transmission .As a secondary aim, immunologic status of the household contacts vaccinated for hepatitis B will be evaluated to assess the efficacy of hepatitis B vaccination and its role in prevention of intra-familial transmission of HBV
Read the detailed description
Hepatitis B virus (HBV) infection is a global health issue; it is estimated that 257 million persons have chronic HBV (Asgeir et al., 2021). The major routes of HBV transmission include blood, sexual contact, vertical (from infected mothers to her children) and horizontal (between the spouses or children) transmission (Şükran et al., (2018). The household transmission of HBV is also a major health issue; it represents a challenge to the health system. Higher rates of HBV infection were reported among the household contacts of chronic HBV carriers; the prevalence of HBV infection among the family members of patients with chronic HBV can reach to 57%. Factors affecting the risk of transmission include socio-demographic status, family role (infected mothers increase the risk of transmission) and viral markers of the index case (Masomeh et al., 2016).The diagnosis of HBV infection is generally based on serological (hepatitis B surface antigen) and molecular assays (hepatitis B virus deoxyribonucleic acid) (Chen et al., 2017).Although the three-dose vaccination for hepatitis B provides more than 90% seroprotection rates (Van Den Ende C, et al, 2017); approximately 10% of vaccinated persons may be at risk of getting infected.
Available data about the current status of intra-familial transmission of HBV among our community members are lacking; we need to determine the magnitude of such a major public health problem
- Conditions
- HBV Transmission
- Keywords
- Intrafamilial transmission of HBV.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the frequency of intra-familial transmission of HBV; & trying to explore the potential risk factors of such a transmission.
Determine the frequency of intra-familial transmission of HBV; \& trying to explore the potential risk factors of such a transmission.
Measured: Baseline.
Secondary outcomes (1)
To assess the efficacy of hepatitis B vaccination and its role in prevention of intra-familial transmission of HBV.
To assess the efficacy of hepatitis B vaccination and its role in prevention of intra-familial transmission of HBV.
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBV TransmissionStudies 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
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Faik Hamed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523921
- Sponsor's protocol ID
- Transmission of HBV
- Status last verified
- Aug 2022
- First submitted
- 29 Aug 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrafamilial Transmission of Hepatitis B Virus: Frequency, Risk Factors, and Role of Hepatitis B Vaccination
- ClinicalTrials.gov ID
- NCT05523921
- Acronym / sponsor ID
- Transmission of HBV
- Conditions
- HBV Transmission
- Keywords
- Intrafamilial transmission of HBV.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 1 Sep 2022 (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.
The primary aim of the study is to accomplish two major tasks: the first is to determine the frequency of intra-familial transmission of HBV; the second is trying to explore the potential risk factors of such a transmission .As a secondary aim, immunologic status of the household contacts vaccinated for hepatitis B will be evaluated to assess the efficacy of hepatitis B vaccination and its role in prevention of intra-familial transmission of HBV
Detailed description
Hepatitis B virus (HBV) infection is a global health issue; it is estimated that 257 million persons have chronic HBV (Asgeir et al., 2021). The major routes of HBV transmission include blood, sexual contact, vertical (from infected mothers to her children) and horizontal (between the spouses or children) transmission (Şükran et al., (2018). The household transmission of HBV is also a major health issue; it represents a challenge to the health system. Higher rates of HBV infection were reported among the household contacts of chronic HBV carriers; the prevalence of HBV infection among the family members of patients with chronic HBV can reach to 57%. Factors affecting the risk of transmission include socio-demographic status, family role (infected mothers increase the risk of transmission) and viral markers of the index case (Masomeh et al., 2016).The diagnosis of HBV infection is generally based on serological (hepatitis B surface antigen) and molecular assays (hepatitis B virus deoxyribonucleic acid) (Chen et al., 2017).Although the three-dose vaccination for hepatitis B provides more than 90% seroprotection rates (Van Den Ende C, et al, 2017); approximately 10% of vaccinated persons may be at risk of getting infected.
Available data about the current status of intra-familial transmission of HBV among our community members are lacking; we need to determine the magnitude of such a major public health problem
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We will provide clinical evaluation, laboratory investigations, and abdominal ultrasonography for every participant of the study. Clinical evaluation will include a detailed questionnaire concerning the potential risk factors of intra-familial transmission of HBV; it will include the kind of family relationship, demographic data, history of hepatitis B vaccination, and the potential routes of HBV transmission. The battery of laboratory work will include hepatitis B surface antigen (for diagnosis of infection), and titer of antibody to hepatitis B surface (for assessment of the immunologic status among non-infected subjects). In addition, liver chemistry panel will be performed for infected patients to help in the assessment of liver disease severity.
Key inclusion criteria (1 listed)
- : The household contacts of patients with chronic HBV infection will be included in the study.
Key exclusion criteria (1 listed)
- Those with prior diagnosis of HBV infection following the date of the primary case infection.
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
Determine the frequency of intra-familial transmission of HBV; & trying to explore the potential risk factors of such a transmission.
Time frame: Baseline.
Determine the frequency of intra-familial transmission of HBV; \& trying to explore the potential risk factors of such a transmission.
1 secondary outcome
To assess the efficacy of hepatitis B vaccination and its role in prevention of intra-familial transmission of HBV.
Time frame: Baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- .Asgeir J, Bitsatab M, Hailemichael D et al., (2021). Mother-to-Child Transmission of Hepatitis B Virus in Ethiopia. Vaccines, 9, 430.Link provided by the sponsor.
- Chen E-Q, Feng S, Wang M, Liang L, Zhou L et al., (2017). Serum hepatitis B core-related antigen is a satisfactory surrogate marker of intrahepatic covalently closed circular DNA in chronic hepatitis B. Sci Rep; 7:173.Link provided by the sponsor.
- Masomeh S, Mohammad B, Masoomeh Z et al., (2016). Intra-familial Transmission of Hepatitis B Virus Infection in Arak, Central Iran. Iran J Pathol; 11(4): 328 - 333Link provided by the sponsor.
- Pournik O, Alavian S, Ghalichi L et al., (2013). Lower intrafamilial transmission rate of hepatitis B in patients with hepatitis d coinfection: a data-miningapproach. Hepat; 13(5).Link provided by the sponsor.
- Şükran K (2018). Laboratory Diagnosis of HBV Viral Hepatitis: Chronic Hepatitis B. p 51-64Link provided by the sponsor.
- Van Den Ende C, et al. The immunogenicity and safety of GSK's recombinant hepatitis B vaccine in adults: a systematic review of 30 years of experience. Expert Rev Vaccines. 2017 16(8):811-832.Link provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of HBV Transmission, 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 1 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: status not confirmed, as of the sponsor's last update on 1 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Faik Hamed, Resident (+201148960065, mohammadfaik9523@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the frequency of intra-familial transmission of HBV; & trying to explore the potential risk factors of such a transmission. (time frame: Baseline.). 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 1 Sep 2022.