HBV InfectionPreMAONCT06184347
Population-wide Research for HBV-related Liver Diseases in Maoming City
An observational study of HBV Infection and Chronic Hepatitis B, run by Nanfang Hospital, Southern Medical University.
Trial summary
Hepatitis B virus (HBV) infection is a major public health problem and chronic HBV infection affects about 296 million people worldwide and is the leading etiology of cirrhosis and hepatocellular carcinoma globally. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- HBV Infection, Chronic Hepatitis B, Cirrhosis
- What is being tested?
- Rapid tests for HBsAg
- How many people
- 3,700,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Aug 2025
- How long will I take part?
- 8 Weeks
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population in Guangdong Province
Who may be able to join
- Screening Group
- Individuals with all the following characteristics can be included:
- Aged from 20 to 70;
- From the residential population of Maoming City, Guangdong Province;
- Voluntarily participate and provide written informed consent forms.
- Control Group
Show all 9Show fewer
- Individuals with all the following characteristics can be included:
- Aged from 20 to 70;
- From the residential population of Wuchuan City and Yangchun City, Guangdong Province.
Who cannot join
- Screening Group
- Individuals with all the following characteristics should be excluded:
- Floating population and temporary residents;
- Diagnosed with severe mental diseases who are unable to communicate normally;
- Determined by the researchers to be unsuitable for this study;
- Control Group The control group data will be collected and organized through relevant systems such as the Guangdong Provincial Center for Disease Control and Prevention, the Cancer Register, and the Population Register, requiring no exclusion.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective and Observational Investigation on Chronic Hepatitis B Virus Infection and Related Liver Diseases Via Systematic Screening in General Population
Hepatitis B virus (HBV) infection is a major public health problem and chronic HBV infection affects about 296 million people worldwide and is the leading etiology of cirrhosis and hepatocellular carcinoma globally. China takes up a great deal of the responsibility towards the goal of "eliminating viral hepatitis by 2030" released by the World Health Organization (WHO), as China has the world's largest burden of HBV infection. The current diagnostic rate barely reaches 24%, which is significantly short of the target diagnostic rate of 90% proposed by WHO. Progression from chronic hepatitis B (CHB) to hepatic complications-fibrosis, cirrhosis, and HCC-can be prevented significantly by preemptive antiviral therapy. However, the onset of CHB seldom manifests with typical symptoms, and most cases at their first diagnosis have progressed to end-stage liver diseases. Therefore, early detection of CHB and its complications that not only raises public awareness of preventing infection but also brings the patients into the management system is urgent blocking the progression to cirrhosis and HCC.
The study is a prospective and observational study involving community-based screening of chronic HBV infection and related liver diseases systematically among the general population of Guangdong Province, China. Individuals in Maoming City, aged 20-70 years, will be enrolled in the screening group for the HBsAg screening using a finger blood test. Positive participants will receive further examinations including laboratory and imaging examinations to discover HBV-related liver diseases. The control group will be enrolled from the general population in two similar cities.
By thoroughly investigating the epidemiological landscape and antiviral situation of chronic hepatitis B through population screening, this study intends to furnish the administration with updated epidemiological data. Additionally, the project seeks to establish a CHB screening cohort to enhance early diagnosis and treatment rates for both HBV-related liver diseases. Collectively, the study aspires to improve the overall prognosis for patients with chronic HBV infection, reduce CHB-related mortality, and ultimately put forward valuable healthcare insights and evidence-based medicine (EBM) practices for the effective implementation of CHB screening and management.
Read the detailed description
Sample selection Individuals aged from 20-70 years old who permanently reside in Maoming City will be enrolled in the screening group.
The natural population from another two cities which share economic, climatic, and customary similarities with Maoming City will be enrolled in the control group.
Participants recruitment Participants who voluntarily attend the screening project will be recruited to the screening group. Personal and medical information of the control group will be fetched from the Guangdong Provincial Center for Disease Control and Prevention, the Cancer Register, the Population Register, and other relevant systems.
Informed consent Informed consent forms will be collected at the recruitment in the screening group.
Questionnaires Questionnaires will be conducted face-to-face by well-trained investigators to gather the personal information of the participants in the screening group and inquire about the previous and current medical history of them and their families concerning viral hepatitis, cirrhosis, and HCC.
HBsAg screening test Participants in the screening group will firstly receive the HBsAg screening using a finger blood test.
Laboratory and imaging examinations Participants positive for the HBsAg screening test in the screening group will undergo further clinical examination to determine if their infections have developed CHB and even HCC. The laboratory examination includes blood routine tests (white blood cell count [WBC], red blood cell count [RBC], hemoglobin [HGB], platelet count [PLT]), liver function (total bilirubin [TBIL], albumin [ALB], alanine aminotransferase [ALT]), HBV serologic markers, alpha-fetoprotein (AFP), abnormal Prothrombin II (PIVKA II) and HBV-DNA. Patients with HBsAg-positive status undergo liver ultrasound examination. If suspicious liver nodules or elevated AFP levels are detected, further refinement through abdominal CT or MRI is recommended.
- Conditions
- HBV Infection, Chronic Hepatitis B, Cirrhosis, HCC
- Being tested
- Rapid tests for HBsAg
- Medical subject headings
- Hepatitis B, Chronic, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid tests for HBsAgOther
Also called Laboratory examination of sample of blood, Imaging examination
Participants in the screening group will firstly receive the HBsAg screening using a finger blood test.
The laboratory examination includes blood routine test (white blood cell count [WBC], red blood cell count [RBC], hemoglobin [HGB], platelet count [PLT]), liver function (total bilirubin [TBIL], albumin [ALB], alanine aminotransferase [ALT]), HBV serologic markers, alpha-fetoprotein(AFP) , abnormal Prothrombin II (PIVKA II) and HBV-DNA.
The imaging examination includes liver ultrasound, abdominal CT, or MRI. HBsAg-positive participants also undergo liver ultrasound examination. If suspicious liver nodules or elevated AFP levels are detected, further refinement through abdominal CT or MRI is recommended.
| Study group | Role | What they receive |
|---|---|---|
| Screening group | All participants will receive an HBsAg finger blood test and a questionnaire gathering their personal information and medical history concerning viral hepatitis, cirrhosis, and hepatocellular carcinoma. Individuals positive for HBsAg will undergo further clinical detections to distinguish dormant liver diseases and HCC. Receives: Other: Rapid tests for HBsAg | |
| Control group | All subjects in this arm will be followed by linkage to the Guangdong Provincial Center for Disease Control and Prevention, Cancer Registry, and Population Registry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the HBV-related liver disease incidences in Guangdong Province
The incidences of HBV-related liver diseases will be calculated as the percentage of patients diagnosed with Hepatitis B, cirrhosis, and HCC in the screening and control groups, which will be used to estimate the HBV-related liver disease incidences in Guangdong Province.
Measured: 2024.02-2025.08
Propotion of participants who are eligible for and would benefit from antiviral therapy.
Propotion of participants who are eligible for and would benefit from antiviral therapy will be based on the percentage of patients who need antiviral therapy after being diagnosed with Hepatitis B, cirrhosis, and HCC in the screening group.
Measured: 2024.02-2025.08
Secondary outcomes (3)
Estimation of the Hepatitis B virus infection rate in Guangdong Province
The Hepatitis B virus infection rate will be based on the percentage of subjects positive for HBV in the screening and control groups, which will be used to estimate the Hepatitis B virus infection rate in Guangdong Province.
Measured: 2024.02-2025.08
Early diagnosis rate of liver cirrhosis or hepatocellular carcinoma
The early diagnosis rate of liver cirrhosis and hepatocellular carcinoma is based on the percentage of CHB patients who have received a confirmed diagnosis of cirrhosis or HCC by the total number of individuals with CHB in the screening group.
Measured: 2024.02-2025.08
The current therapeutic rate of chronic hepatitis B
The current therapeutic coverage of chronic hepatitis B will be based on the percentage of patients who accepted antiviral therapy after being diagnosed with HBV infection before screening.
Measured: 2024.02-2025.08
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study startFeb 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HBV InfectionStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical 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
- 3,700,000 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Liu, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184347
- Sponsor's protocol ID
- NFEC-2023-474
- Acronym
- PreMAO
- Status last verified
- Jan 2024
- First submitted
- 13 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jeng WJ, Papatheodoridis GV, Lok ASF. Hepatitis B. Lancet. 2023 Mar 25;401(10381):1039-1052. doi: 10.1016/S0140-6736(22)01468-4. Epub 2023 Feb 9.
PubMed 36774930Liu Z, Lin C, Mao X, Guo C, Suo C, Zhu D, Jiang W, Li Y, Fan J, Song C, Zhang T, Jin L, De Martel C, Clifford GM, Chen X. Changing prevalence of chronic hepatitis B virus infection in China between 1973 and 2021: a systematic literature review and meta-analysis of 3740 studies and 231 million people. Gut. 2023 Nov 24;72(12):2354-2363. doi: 10.1136/gutjnl-2023-330691.
PubMed 37798085Su S, Wong WC, Zou Z, Cheng DD, Ong JJ, Chan P, Ji F, Yuen MF, Zhuang G, Seto WK, Zhang L. Cost-effectiveness of universal screening for chronic hepatitis B virus infection in China: an economic evaluation. Lancet Glob Health. 2022 Feb;10(2):e278-e287. doi: 10.1016/S2214-109X(21)00517-9.
PubMed 35063115Hsu YC, Huang DQ, Nguyen MH. Global burden of hepatitis B virus: current status, missed opportunities and a call for action. Nat Rev Gastroenterol Hepatol. 2023 Aug;20(8):524-537. doi: 10.1038/s41575-023-00760-9. Epub 2023 Apr 6.
PubMed 37024566
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Observational Investigation on Chronic Hepatitis B Virus Infection and Related Liver Diseases Via Systematic Screening in General Population
- ClinicalTrials.gov ID
- NCT06184347
- Acronym / sponsor ID
- PreMAO / NFEC-2023-474
- Conditions
- HBV Infection, Chronic Hepatitis B, Cirrhosis, HCC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,700,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 28 Dec 2023 (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.
Hepatitis B virus (HBV) infection is a major public health problem and chronic HBV infection affects about 296 million people worldwide and is the leading etiology of cirrhosis and hepatocellular carcinoma globally. China takes up a great deal of the responsibility towards the goal of "eliminating viral hepatitis by 2030" released by the World Health Organization (WHO), as China has the world's largest burden of HBV infection. The current diagnostic rate barely reaches 24%, which is significantly short of the target diagnostic rate of 90% proposed by WHO. Progression from chronic hepatitis B (CHB) to hepatic complications-fibrosis, cirrhosis, and HCC-can be prevented significantly by preemptive antiviral therapy. However, the onset of CHB seldom manifests with typical symptoms, and most cases at their first diagnosis have progressed to end-stage liver diseases. Therefore, early detection of CHB and its complications that not only raises public awareness of preventing infection but also brings the patients into the management system is urgent blocking the progression to cirrhosis and HCC.
The study is a prospective and observational study involving community-based screening of chronic HBV infection and related liver diseases systematically among the general population of Guangdong Province, China. Individuals in Maoming City, aged 20-70 years, will be enrolled in the screening group for the HBsAg screening using a finger blood test. Positive participants will receive further examinations including laboratory and imaging examinations to discover HBV-related liver diseases. The control group will be enrolled from the general population in two similar cities.
By thoroughly investigating the epidemiological landscape and antiviral situation of chronic hepatitis B through population screening, this study intends to furnish the administration with updated epidemiological data. Additionally, the project seeks to establish a CHB screening cohort to enhance early diagnosis and treatment rates for both HBV-related liver diseases. Collectively, the study aspires to improve the overall prognosis for patients with chronic HBV infection, reduce CHB-related mortality, and ultimately put forward valuable healthcare insights and evidence-based medicine (EBM) practices for the effective implementation of CHB screening and management.
Detailed description
Sample selection Individuals aged from 20-70 years old who permanently reside in Maoming City will be enrolled in the screening group.
The natural population from another two cities which share economic, climatic, and customary similarities with Maoming City will be enrolled in the control group.
Participants recruitment Participants who voluntarily attend the screening project will be recruited to the screening group. Personal and medical information of the control group will be fetched from the Guangdong Provincial Center for Disease Control and Prevention, the Cancer Register, the Population Register, and other relevant systems.
Informed consent Informed consent forms will be collected at the recruitment in the screening group.
Questionnaires Questionnaires will be conducted face-to-face by well-trained investigators to gather the personal information of the participants in the screening group and inquire about the previous and current medical history of them and their families concerning viral hepatitis, cirrhosis, and HCC.
HBsAg screening test Participants in the screening group will firstly receive the HBsAg screening using a finger blood test.
Laboratory and imaging examinations Participants positive for the HBsAg screening test in the screening group will undergo further clinical examination to determine if their infections have developed CHB and even HCC. The laboratory examination includes blood routine tests (white blood cell count [WBC], red blood cell count [RBC], hemoglobin [HGB], platelet count [PLT]), liver function (total bilirubin [TBIL], albumin [ALB], alanine aminotransferase [ALT]), HBV serologic markers, alpha-fetoprotein (AFP), abnormal Prothrombin II (PIVKA II) and HBV-DNA. Patients with HBsAg-positive status undergo liver ultrasound examination. If suspicious liver nodules or elevated AFP levels are detected, further refinement through abdominal CT or MRI is recommended.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening group | – | Other: Rapid tests for HBsAgAll participants will receive an HBsAg finger blood test and a questionnaire gathering their personal information and medical history concerning viral hepatitis, cirrhosis, and hepatocellular carcinoma. Individuals positive for HBsAg will undergo further clinical detections to distinguish dormant liver diseases and HCC. |
| Control group | – | –All subjects in this arm will be followed by linkage to the Guangdong Provincial Center for Disease Control and Prevention, Cancer Registry, and Population Registry. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population in Guangdong Province
Key inclusion criteria (9 listed)
- Screening Group
- Control Group
- Aged from 20 to 70;
- From the residential population of Wuchuan City and Yangchun City, Guangdong Province.
Key exclusion criteria (6 listed)
- Screening Group
- Control Group The control group data will be collected and organized through relevant systems such as the Guangdong Provincial Center for Disease Control and Prevention, the Cancer Register, and the Population Register, requiring no exclusion.
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 |
|---|---|---|
| Rapid tests for HBsAgAlso: Laboratory examination of sample of blood, Imaging examinationParticipants in the screening group will firstly receive the HBsAg screening using a finger blood test. The laboratory examination includes blood routine test (white blood cell count [WBC], red blood cell count [RBC], hemoglobin [HGB], platelet count [PLT]), liver function (total bilirubin [TBIL], albumin [ALB], alanine aminotransferase [ALT]), HBV serologic markers, alpha-fetoprotein(AFP) , abnormal Prothrombin II (PIVKA II) and HBV-DNA. The imaging examination includes liver ultrasound, abdominal CT, or MRI. HBsAg-positive participants also undergo liver ultrasound examination. If suspicious liver nodules or elevated AFP levels are detected, further refinement through abdominal CT or MRI is recommended. | Other | Screening group |
Primary outcome
Estimation of the HBV-related liver disease incidences in Guangdong Province
Time frame: 2024.02-2025.08
The incidences of HBV-related liver diseases will be calculated as the percentage of patients diagnosed with Hepatitis B, cirrhosis, and HCC in the screening and control groups, which will be used to estimate the HBV-related liver disease incidences in Guangdong Province.
Propotion of participants who are eligible for and would benefit from antiviral therapy.
Time frame: 2024.02-2025.08
Propotion of participants who are eligible for and would benefit from antiviral therapy will be based on the percentage of patients who need antiviral therapy after being diagnosed with Hepatitis B, cirrhosis, and HCC in the screening group.
3 secondary outcomes
Estimation of the Hepatitis B virus infection rate in Guangdong Province
Time frame: 2024.02-2025.08
Early diagnosis rate of liver cirrhosis or hepatocellular carcinoma
Time frame: 2024.02-2025.08
The current therapeutic rate of chronic hepatitis B
Time frame: 2024.02-2025.08
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Background: PubMed 36774930Jeng WJ, Papatheodoridis GV, Lok ASF. Hepatitis B. Lancet. 2023 Mar 25;401(10381):1039-1052. doi: 10.1016/S0140-6736(22)01468-4. Epub 2023 Feb 9.
- Background: PubMed 37798085Liu Z, Lin C, Mao X, Guo C, Suo C, Zhu D, Jiang W, Li Y, Fan J, Song C, Zhang T, Jin L, De Martel C, Clifford GM, Chen X. Changing prevalence of chronic hepatitis B virus infection in China between 1973 and 2021: a systematic literature review and meta-analysis of 3740 studies and 231 million people. Gut. 2023 Nov 24;72(12):2354-2363. doi: 10.1136/gutjnl-2023-330691.
- Background: PubMed 35063115Su S, Wong WC, Zou Z, Cheng DD, Ong JJ, Chan P, Ji F, Yuen MF, Zhuang G, Seto WK, Zhang L. Cost-effectiveness of universal screening for chronic hepatitis B virus infection in China: an economic evaluation. Lancet Glob Health. 2022 Feb;10(2):e278-e287. doi: 10.1016/S2214-109X(21)00517-9.
- Background: PubMed 37024566Hsu YC, Huang DQ, Nguyen MH. Global burden of hepatitis B virus: current status, missed opportunities and a call for action. Nat Rev Gastroenterol Hepatol. 2023 Aug;20(8):524-537. doi: 10.1038/s41575-023-00760-9. Epub 2023 Apr 6.
- HBV progress towards coverage targetsLink 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.
Li Liu principal investigator
Nanfang Hospital, Southern Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of HBV Infection and Chronic Hepatitis B, run by Nanfang Hospital, Southern Medical 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 9 inclusion and 6 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 9 Jan 2024. 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 Li Liu (+86 18602062738, liuli@i.smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the HBV-related liver disease incidences in Guangdong Province (time frame: 2024.02-2025.08). 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 NCT06184347, which also lists 4 linked publications.
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 9 Jan 2024.