Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03425513
Other study ID # HBVBE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 12, 2017
Est. completion date November 27, 2017

Study information

Verified date January 2020
Source Hasselt University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1131
Est. completion date November 27, 2017
Est. primary completion date November 27, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Age between 18 and 70

- Males and females

Exclusion Criteria:

/

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Hepatitis B serology
A serum specimen will be taken and assessed for hepatitis B serology (HBsAg and anti-HBc antibodies).
Other:
Questionnaire
Participants will be asked to fill in a questionnaire regarding demographic characteristics, known viral hepatitis status and risk factors for HBV infection.

Locations

Country Name City State
Belgium Ziekenhuis Oost-Limburg Genk Limburg

Sponsors (1)

Lead Sponsor Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Seroprevalence of current HBV infection in the Middle Limburg population Serum HBsAg 1 day
Primary Seroprevalence of past or current HBV infection in the Middle Limburg population Serum anti-HBc antibodies 1 day
Secondary 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. 1 day
Secondary 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. 1 day
See also
  Status Clinical Trial Phase
Completed NCT01182311 - Duration of Long-term Immunity After Hepatitis B Virus Immunization
Completed NCT04971928 - Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment Phase 1
Completed NCT03285620 - A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants Phase 1
Completed NCT01884415 - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis Phase 3
Recruiting NCT05404919 - Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates Phase 2
Completed NCT02153320 - Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers Phase 1
Completed NCT00352963 - Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age). Phase 3
Completed NCT03567382 - Arresting Vertical Transmission of Hepatitis B Virus Phase 4
Not yet recruiting NCT04056728 - A Phase IV Study to Assess the Safety of EupentaTM Inj Phase 4
Not yet recruiting NCT03604016 - Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver Phase 4
Completed NCT00753649 - Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants Phase 4
Recruiting NCT03027258 - Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome N/A
Terminated NCT02604199 - A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection Phase 2
Completed NCT02540538 - Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders Phase 1
Completed NCT02169674 - Hepatitis B Booster Study in Adolescence Phase 4
Completed NCT02421666 - A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV N/A
Completed NCT01917357 - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject Phase 3
Completed NCT01732354 - Study for Consolidation Period of Chronic Hepatitis B
Completed NCT01368497 - Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection Phase 3
Recruiting NCT01462981 - Cohort of Hepatitis B Research of Amsterdam N/A