Hepatitis BHBVBENCT03425513
Hepatitis B Virus Prevalence and Risk Factors in Belgium
An observational study of Hepatitis B, run by Hasselt University at 1 site in Belgium.
Trial summary
The aim of this study was to evaluate the current prevalence and risk factors of hepatitis B virus (HBV) infection in a multi-ethnic neighbourhood situated in Middle Limburg, Belgium. Additionally, the investigators will determine linkage of care in hepatitis B surface antigen (HBsAg) positive subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Hepatitis B serology and Questionnaire
- How many people
- 1,131 participants
- Where
- 1 siteBelgium
- Study dates
- 12 May 2017to 27 Nov 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients between the age of 18 and 70 who presented at the emergency department of Ziekenhuis Oost-Limburg, a large hospital in Genk, situated in Middle Limburg.
Who may be able to join
- Age between 18 and 70
- Males and females
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatitis B Virus Prevalence and Risk Factors in Middle Limburg Belgium: the Importance of Migration.
The aim of this study was to evaluate the current prevalence and risk factors of hepatitis B virus (HBV) infection in a multi-ethnic neighbourhood situated in Middle Limburg, Belgium. Additionally, the investigators will determine linkage of care in hepatitis B surface antigen (HBsAg) positive subjects.
Read the detailed description
Although the HBV prevalence is generally low in Western countries, such as Belgium, pockets of higher HBV prevalence exist in areas with large immigrant populations. Therefore national prevalence figures can underestimate the burden of HBV infection. The prevalence of chronic HBV in the population-based study in 2003 is believed to be an underestimate due to under-representation of the non-Belgian population. Moreover, by this time there are no data regarding the risk factors for HBV infection in the general population of Belgium.
Even in low-prevalence areas such as Belgium, HBV prevention and control is a public health priority, particularly since safe and effective vaccines are available. The aim of this study was to evaluate the current prevalence and risk factors of HBV infection in a multi-ethnic neighbourhood situated in Middle Limburg, Belgium. Additionally, the investigators will determine linkage of care in hepatitis B surface antigen (HBsAg) positive subjects.
- Conditions
- Hepatitis B
- Being tested
- Hepatitis B serology, Questionnaire
- Keywords
- Belgium, Prevalence, Risk factor, Ethnicity, Linkage of care
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis B serologyDiagnostic test
A serum specimen will be taken and assessed for hepatitis B serology (HBsAg and anti-HBc antibodies).
QuestionnaireOther
Participants will be asked to fill in a questionnaire regarding demographic characteristics, known viral hepatitis status and risk factors for HBV infection.
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis B group | Not described Receives: Diagnostic Test: Hepatitis B serology; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprevalence of current HBV infection in the Middle Limburg population
Serum HBsAg
Measured: 1 day
Seroprevalence of past or current HBV infection in the Middle Limburg population
Serum anti-HBc antibodies
Measured: 1 day
Secondary outcomes (2)
Assess risk factors for current HBV infection in the Middle Limburg population
Combine results from (1) serum HBsAg with (2) questionnaire regarding demographic characteristics, known viral hepatitis status and risk factors for HBV infection.
Measured: 1 day
Assess risk factors for past or current HBV infection in the Middle Limburg population
Combine results from (1) serum anti-HBc antibodies with (2) questionnaire regarding demographic characteristics, known viral hepatitis status and risk factors for HBV infection.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start12 May 2017
- Primary completion27 Nov 2017
- Study completion27 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geert Robaeys, Hasselt University
- Investigators
- Geert Robaeys, M.D., Ph.D., Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425513
- Sponsor's protocol ID
- HBVBE
- Acronym
- HBVBE
- Status last verified
- Jan 2020
- First submitted
- 1 Feb 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis B Virus Prevalence and Risk Factors in Middle Limburg Belgium: the Importance of Migration.
- ClinicalTrials.gov ID
- NCT03425513
- Acronym / sponsor ID
- HBVBE / HBVBE
- Conditions
- Hepatitis B
- Keywords
- Belgium, Prevalence, Risk factor, Ethnicity, Linkage of care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,131 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- 27 Nov 2017 (actual)
- Study completion
- 27 Nov 2017 (actual)
- First posted
- 7 Feb 2018 (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 aim of this study was to evaluate the current prevalence and risk factors of hepatitis B virus (HBV) infection in a multi-ethnic neighbourhood situated in Middle Limburg, Belgium. Additionally, the investigators will determine linkage of care in hepatitis B surface antigen (HBsAg) positive subjects.
Detailed description
Although the HBV prevalence is generally low in Western countries, such as Belgium, pockets of higher HBV prevalence exist in areas with large immigrant populations. Therefore national prevalence figures can underestimate the burden of HBV infection. The prevalence of chronic HBV in the population-based study in 2003 is believed to be an underestimate due to under-representation of the non-Belgian population. Moreover, by this time there are no data regarding the risk factors for HBV infection in the general population of Belgium.
Even in low-prevalence areas such as Belgium, HBV prevention and control is a public health priority, particularly since safe and effective vaccines are available. The aim of this study was to evaluate the current prevalence and risk factors of HBV infection in a multi-ethnic neighbourhood situated in Middle Limburg, Belgium. Additionally, the investigators will determine linkage of care in hepatitis B surface antigen (HBsAg) positive subjects.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis B group | – | Diagnostic Test: Hepatitis B serology, Other: Questionnaire |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients between the age of 18 and 70 who presented at the emergency department of Ziekenhuis Oost-Limburg, a large hospital in Genk, situated in Middle Limburg.
Key inclusion criteria (2 listed)
- Age between 18 and 70
- Males and females
Key exclusion criteria (1 listed)
- /
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatitis B serologyA serum specimen will be taken and assessed for hepatitis B serology (HBsAg and anti-HBc antibodies). | Diagnostic test | Hepatitis B group |
| QuestionnaireParticipants will be asked to fill in a questionnaire regarding demographic characteristics, known viral hepatitis status and risk factors for HBV infection. | Other | Hepatitis B group |
Primary outcome
Seroprevalence of current HBV infection in the Middle Limburg population
Time frame: 1 day
Serum HBsAg
Seroprevalence of past or current HBV infection in the Middle Limburg population
Time frame: 1 day
Serum anti-HBc antibodies
2 secondary outcomes
Assess risk factors for current HBV infection in the Middle Limburg population
Time frame: 1 day
Assess risk factors for past or current HBV infection in the Middle Limburg population
Time frame: 1 day
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 27 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
Geert Robaeys, M.D., Ph.D. principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Hasselt University at 1 site in Belgium.
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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Seroprevalence of current HBV infection in the Middle Limburg population (time frame: 1 day). 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 27 Jan 2020.