Viral HepatitisNCT04371276
Seroepidemiology of Viral Hepatitis in Hong Kong
An observational study of Viral Hepatitis, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Immunisation policies have strong influences on the epidemiology of hepatitis A and B infection. In Hong Kong, vaccines against both viruses have been available through different channels and programmes in the past 3 decades. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Viral Hepatitis
- How many people
- 2,888 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 31 May 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Residents of Building Groups from diverse geographical locations in Hong Kong selected through cluster sampling are targeted. With the building information available, three households would be randomly selected from each Building Group.
Who may be able to join
- residents normally living in Hong Kong
- living in domestic households randomly selected from Building Groups
- Any age, while subjects below the age of 18 would require informed consent of their guardians for participation
- Any gender
Who cannot join
- unable to understand written Chinese or English,
- failure to give consent for participation
- living in institution or non-domestic housing,
- foreign domestic helpers,
- normally living in Hong Kong
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Seroepidemiology of Hepatitis A and B in the General Population for Informing the Development of New Hepatitis Vaccination Strategies in Hong Kong
Immunisation policies have strong influences on the epidemiology of hepatitis A and B infection. In Hong Kong, vaccines against both viruses have been available through different channels and programmes in the past 3 decades. To evaluate the changes in the prevalence of hepatitis A and B in the general population, a seroepidemiology study is conducted involving a prospective cross-sectional survey followed for serology testing. Eligible members of 1327 spatially random households would be invited to join the study by completing a questionnaire and providing blood samples, either by dried blood spots or venesection, for determining the presence of antigen and/or antibody against hepatitis B, as well as antibody against hepatitis A. The main measures comprise a set of metrics on the prevalence of hepatitis A and B. Analysis would be conducted to examine the association of risk factors with the tested markers and describe the attitudes towards viral hepatitis vaccination. The results would allow us to understand the transmission potential of hepatitis A and B in the community would be influenced by the changing disease epidemiology and coverage of vaccination, which inform the development of new vaccination strategies in Hong Kong
- Conditions
- Viral Hepatitis
- Being tested
- No intervention
- Keywords
- hepatitis A, hepatitis B, epidemiology
- Medical subject headings
- Hepatitis A, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Also called blood sampling for serology testing
Blood samples will be collected from recruited subjects from invited households for testing for hepatitis B (HBsAg, anti-HBs and anti-HBc) and hepatitis A (anti-HAV)
What is being measured
The primary outcome is the main question the study is designed to answer.
hepatitis B infection prevalence
Proportion of individuals with positive HBsAg
Measured: 12 months
hepatitis A immunity prevalence
Proportion of individuals with positive IgG against HAV
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start1 Sep 2018
- Primary completion31 Dec 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Viral HepatitisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,888 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shui-Shan Lee, MD, Chinese University of Hong Kong
- Investigators
- Shui Shan Lee, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371276
- Sponsor's protocol ID
- 17160962
- Status last verified
- Feb 2023
- First submitted
- 29 Apr 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poon CM, Chan DP, Lee SS, Wong NS. Seroepidemiology of hepatitis A and B in the general population in Hong Kong: protocol of a cross-sectional survey using spatial sampling in a highly urbanised city. BMJ Open. 2021 Mar 22;11(3):e042065. doi: 10.1136/bmjopen-2020-042065.
PubMed 33753433
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Seroepidemiology of Hepatitis A and B in the General Population for Informing the Development of New Hepatitis Vaccination Strategies in Hong Kong
- ClinicalTrials.gov ID
- NCT04371276
- Acronym / sponsor ID
- 17160962
- Conditions
- Viral Hepatitis
- Keywords
- hepatitis A, hepatitis B, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,888 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 1 May 2020 (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.
Immunisation policies have strong influences on the epidemiology of hepatitis A and B infection. In Hong Kong, vaccines against both viruses have been available through different channels and programmes in the past 3 decades. To evaluate the changes in the prevalence of hepatitis A and B in the general population, a seroepidemiology study is conducted involving a prospective cross-sectional survey followed for serology testing. Eligible members of 1327 spatially random households would be invited to join the study by completing a questionnaire and providing blood samples, either by dried blood spots or venesection, for determining the presence of antigen and/or antibody against hepatitis B, as well as antibody against hepatitis A. The main measures comprise a set of metrics on the prevalence of hepatitis A and B. Analysis would be conducted to examine the association of risk factors with the tested markers and describe the attitudes towards viral hepatitis vaccination. The results would allow us to understand the transmission potential of hepatitis A and B in the community would be influenced by the changing disease epidemiology and coverage of vaccination, which inform the development of new vaccination strategies in Hong Kong
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents of Building Groups from diverse geographical locations in Hong Kong selected through cluster sampling are targeted. With the building information available, three households would be randomly selected from each Building Group.
Key inclusion criteria (4 listed)
- residents normally living in Hong Kong
- living in domestic households randomly selected from Building Groups
- Any age, while subjects below the age of 18 would require informed consent of their guardians for participation
- Any gender
Key exclusion criteria (5 listed)
- unable to understand written Chinese or English,
- failure to give consent for participation
- living in institution or non-domestic housing,
- foreign domestic helpers,
- normally living in Hong Kong
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 |
|---|---|---|
| No interventionAlso: blood sampling for serology testingBlood samples will be collected from recruited subjects from invited households for testing for hepatitis B (HBsAg, anti-HBs and anti-HBc) and hepatitis A (anti-HAV) | Other | – |
Primary outcome
hepatitis B infection prevalence
Time frame: 12 months
Proportion of individuals with positive HBsAg
hepatitis A immunity prevalence
Time frame: 12 months
Proportion of individuals with positive IgG against HAV
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 8 Feb 2023.
- Derived from this study: PubMed 33753433Poon CM, Chan DP, Lee SS, Wong NS. Seroepidemiology of hepatitis A and B in the general population in Hong Kong: protocol of a cross-sectional survey using spatial sampling in a highly urbanised city. BMJ Open. 2021 Mar 22;11(3):e042065. doi: 10.1136/bmjopen-2020-042065.
- Individual participant dataSharing planned: No
Related trials for Viral Hepatitis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
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.
Shui Shan Lee, MD principal investigator
Chinese University of Hong Kong
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 Viral Hepatitis, run by Chinese University of Hong Kong at 1 site in China.
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 4 inclusion and 5 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 8 Feb 2023. 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 China. 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?
hepatitis B infection prevalence (time frame: 12 months). 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?
On the ClinicalTrials.gov record for NCT04371276, which also lists 1 linked publication.
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 8 Feb 2023.