Observe and Describe the Prevalence of Hepatitis D Infection Among HBsAg Positive PeopleNCT04483518
Epidemiological Survey of Hepatitis D Virus Infection in China
An observational study of Observe and Describe the Prevalence of Hepatitis D Infection Among HBsAg Positive People, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This cross-sectional study will screen out hepatitis D virus-infected patients in HBsAg-positive people. Observe and describe the prevalence of hepatitis D infection among HBsAg positive people. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Observe and Describe the Prevalence of Hepatitis D Infection Among HBsAg Positive People
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2019to 7 Jul 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hepatitis B surface antigen or HBV DNA positive
Who may be able to join
- Hepatitis B surface antigen or HBV DNA positive
Who cannot join
- Can't sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiological Survey of Hepatitis D Virus Infection in Hepatitis B Population Among Multi-center Hepatitis B Population in China
This cross-sectional study will screen out hepatitis D virus-infected patients in HBsAg-positive people. Observe and describe the prevalence of hepatitis D infection among HBsAg positive people. The provinces of China are divided into 5 geographical areas (North, South, East, West and Central) to recruit patients according to the population density of each area. After statistical calculation, the total number of population needed is 3808.
Read the detailed description
Entry criteria：1. Age 18 years and above. 2. male or female. 3. Diagnosed as chronic HBV infection (HBsAg positive) 4.Ability to sign informed consent.
Exclusion criteria：Patients who disagree to participate in the trial.
After the informed consent was signed, the quantitative data of the previous surface antigen or HBV DNA titer was collected during the return visit. 4 ml of venous blood was collected on the same day or the remaining serum from the surface antigen or hepatitis B quantitative test was collected for the detection of hepatitis D antibody and/or the quantitative detection of hepatitis D RNA.
After statistical analysis, calculate the hepatitis D infection status in China.
- Keywords
- HBsAg positive, HBV DNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HBV patients | HBV patients with HBsAg positive and/or HBV DNA positive |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of hepatitis D virus
Proportion of hepatitis D infection in people with hepatitis B infection
Measured: 2019-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start3 Jun 2019
- Primary completion7 Jul 2020
- Study completion7 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Observe and Describe the Prevalence of Hepatitis D Infection Among HBsAg Positive PeopleStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- Cross-sectional
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, The Fourth Affiliated Hospital of Harbin Medical University, Shandong Provincial Hospital, Ruijin Hospital
- Responsible party
- Principal investigator, Junqi Niu, The First Hospital of Jilin University
- Investigators
- Junqi Niu, Dr., Study director, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483518
- Sponsor's protocol ID
- 19K056-001
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Infection rate data
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Survey of Hepatitis D Virus Infection in Hepatitis B Population Among Multi-center Hepatitis B Population in China
- ClinicalTrials.gov ID
- NCT04483518
- Acronym / sponsor ID
- 19K056-001
- Keywords
- HBsAg positive, HBV DNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, The Fourth Affiliated Hospital of Harbin Medical University, Shandong Provincial Hospital, Ruijin Hospital
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 23 Jul 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.
This cross-sectional study will screen out hepatitis D virus-infected patients in HBsAg-positive people. Observe and describe the prevalence of hepatitis D infection among HBsAg positive people. The provinces of China are divided into 5 geographical areas (North, South, East, West and Central) to recruit patients according to the population density of each area. After statistical calculation, the total number of population needed is 3808.
Detailed description
Entry criteria：1. Age 18 years and above. 2. male or female. 3. Diagnosed as chronic HBV infection (HBsAg positive) 4.Ability to sign informed consent.
Exclusion criteria：Patients who disagree to participate in the trial.
After the informed consent was signed, the quantitative data of the previous surface antigen or HBV DNA titer was collected during the return visit. 4 ml of venous blood was collected on the same day or the remaining serum from the surface antigen or hepatitis B quantitative test was collected for the detection of hepatitis D antibody and/or the quantitative detection of hepatitis D RNA.
After statistical analysis, calculate the hepatitis D infection status in China.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBV patients | – | –HBV patients with HBsAg positive and/or HBV DNA positive |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hepatitis B surface antigen or HBV DNA positive
Key inclusion criteria (1 listed)
- Hepatitis B surface antigen or HBV DNA positive
Key exclusion criteria (1 listed)
- Can't sign informed consent
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
The prevalence of hepatitis D virus
Time frame: 2019-2020
Proportion of hepatitis D infection in people with hepatitis B infection
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 23 Jul 2020.
- Individual participant dataSharing planned: No. Infection rate data
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.
Junqi Niu, Dr. study director
The First Hospital of Jilin 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 Observe and Describe the Prevalence of Hepatitis D Infection Among HBsAg Positive People, run by The First Hospital of Jilin University 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 1 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 23 Jul 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 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?
The prevalence of hepatitis D virus (time frame: 2019-2020). 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 23 Jul 2020.