Hepatitis BNCT04264312
Baseline Investigation of Chronic Hepatitis B Viruses Infections: Who is Eligible for Treated Criteria
An observational study of Hepatitis B, run by Wu Jiang at 11 sites in China.
Trial summary
Through two-stage stratified cluster sampling, investigators studied the antiviral treatment rate and the main factors affecting the antiviral treatment in community chronic HBV infection-related liver disease population. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Hepatitis B
- How many people
- 76,220 participants
- Where
- 11 sitesChina
- Study dates
- 28 Jul 2017to 10 Jan 2020
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population are Residents with medical insurance who were older than 25 years and lived in Beijing more than 6 months. The population who are with pacemakers and ascites, pregnant, and whose wound was not cured at right upper abdomen were excluded.
Who may be able to join
- older than 25 years old;
- Residents with medical insurance coverage lived in Beijing more than 6 months .
Who cannot join
- Persons with pacemakers;
- Pregnant women;
- Persons with ascites;
- The one whose wound was not cured at the right upper abdomen
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Xicheng District Center for Disease Prevention and Control
Beijing, Beijing Municipality, 100120
Huairou District Center for Disease Prevention and Control
Beijing, Beijing Municipality, 101400
Daxing District Center for Disease Prevention and Control
Beijing, Beijing Municipality, 102600
Chaoyang District Center for Disease Control and Prevention
Beijing, Beijing Municipality
Dongcheng District Center for Disease Control and Prevention
Beijing, Beijing Municipality
Fengtai District Center for Disease Control and Prevention
Beijing, Beijing Municipality
Changping District Center for Disease Prevention and Control
Beijing
FangShan District Center for Disease Prevention and Control
Beijing
Haidian District Center for Disease Prevention and Control
Beijing
Miyun District Center for Disease Prevention and Control
Beijing
Tongzhou District Center for Disease Prevention and Control
Beijing
About this study
Official title: Beijing Center for Disease Prevention and Control
Through two-stage stratified cluster sampling, investigators studied the antiviral treatment rate and the main factors affecting the antiviral treatment in community chronic HBV infection-related liver disease population.
Read the detailed description
Hepatitis B virus (HBV) infection is a major public health problem worldwide. China has the world's largest burden of HBV infection and will be a major contributor towards the global elimination of hepatitis B disease by 2030. While, the antiviral treatment rate and the main factors affecting the antiviral treatment in community chronic HBV infections is still unknown. In response to the above situation, Sampling applied a two-stage stratified cluster sampling design in 16 Districts and 331 Townships. Investigators wanted to know the one who is eligible for treated criteria based on community in 25 and over years old in Beijing.
- Conditions
- Hepatitis B
- Keywords
- HBV, Antiviral Treatment Rate, China, Baseline Investigation
- Medical subject headings
- Hepatitis B
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg positive rate
Complete HBsAg tests for more than 60,000 people over the age of 25 in Beijing
Measured: Baseline
Average rate of chronic hepatitis B accepting antiviral treatment
The one who is eligible for HBV treated criteria based on community in 25 and over years old in Beijing.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start28 Jul 2017
- Primary completion28 Sep 2019
- Study completion10 Jan 2020
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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 76,220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wu Jiang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Wu Jiang, Centers for Disease Control and Prevention, China
- Investigators
- Jiang Wu, Study director, Beijing Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264312
- Sponsor's protocol ID
- BJCDCWJ202001
- Status last verified
- Feb 2020
- First submitted
- 4 Feb 2020
- Last updated
- 11 Feb 2020
- 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 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beijing Center for Disease Prevention and Control
- ClinicalTrials.gov ID
- NCT04264312
- Acronym / sponsor ID
- BJCDCWJ202001
- Conditions
- Hepatitis B
- Keywords
- HBV, Antiviral Treatment Rate, China, Baseline Investigation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76,220 participants (actual)
- Lead sponsor
- Wu JiangOther government
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 28 Sep 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 11 Feb 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.
Through two-stage stratified cluster sampling, investigators studied the antiviral treatment rate and the main factors affecting the antiviral treatment in community chronic HBV infection-related liver disease population.
Detailed description
Hepatitis B virus (HBV) infection is a major public health problem worldwide. China has the world's largest burden of HBV infection and will be a major contributor towards the global elimination of hepatitis B disease by 2030. While, the antiviral treatment rate and the main factors affecting the antiviral treatment in community chronic HBV infections is still unknown. In response to the above situation, Sampling applied a two-stage stratified cluster sampling design in 16 Districts and 331 Townships. Investigators wanted to know the one who is eligible for treated criteria based on community in 25 and over years old in Beijing.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population are Residents with medical insurance who were older than 25 years and lived in Beijing more than 6 months. The population who are with pacemakers and ascites, pregnant, and whose wound was not cured at right upper abdomen were excluded.
Key inclusion criteria (2 listed)
- older than 25 years old;
- Residents with medical insurance coverage lived in Beijing more than 6 months .
Key exclusion criteria (4 listed)
- Persons with pacemakers;
- Pregnant women;
- Persons with ascites;
- The one whose wound was not cured at the right upper abdomen
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
HBsAg positive rate
Time frame: Baseline
Complete HBsAg tests for more than 60,000 people over the age of 25 in Beijing
Average rate of chronic hepatitis B accepting antiviral treatment
Time frame: Baseline
The one who is eligible for HBV treated criteria based on community in 25 and over years old in Beijing.
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 11 Feb 2020.
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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.
Jiang Wu study director
Beijing Center for Disease Prevention and Control
11 sites 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 Wu Jiang at 11 sites 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 2 inclusion and 4 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 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
HBsAg positive rate (time frame: Baseline). 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 11 Feb 2020.