Chronic Hepatitis BHBV IMDRNCT06779864
Molecular Characteristics of Hepatitis B Virus Integration, Mutation, and Drug Resistance
An observational study of Chronic Hepatitis B, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Patients with a confirmed diagnosis of chronic hepatitis B (CHB) who have complete clinical data and retained blood or liver tissue samples will be enrolled. All patients will be grouped based on cohort sources: the Antiviral Treatment Cohort and the Cross-Sectional Epidemiological Survey Cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hepatitis B surface antigen positive, who have complete clinical data and retained blood samples or liver tissue samples.
Who may be able to join
- Patients with hepatitis B surface antigen positive.
- Patients who have complete demographic information, clinical data and retained blood samples or liver tissue samples
Who cannot join
- Subject who without blood samples or liver tissue samples
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Xiaoning Wu, Dr., 86+(010)6313-86686, byfriendship145@163.com
About this study
Patients with a confirmed diagnosis of chronic hepatitis B (CHB) who have complete clinical data and retained blood or liver tissue samples will be enrolled. All patients will be grouped based on cohort sources: the Antiviral Treatment Cohort and the Cross-Sectional Epidemiological Survey Cohort.
Patients in the Antiviral Treatment Cohort have received antiviral treatment and are followed every six months. During follow-up, HBV-related endpoint events, including cirrhosis decompensations (such as ascites, esophageal variceal bleeding, and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplantation, and liver-related death, will be collected.
Read more
In the Cross-Sectional Epidemiological Survey Cohort, clinical data will be collected at a single time point, with some patients not receiving antiviral treatment.
In both cohorts, retained blood and liver tissue samples will be used to further analyze HBV genotypes, viral integration, drug resistance, and the molecular characteristics of mutations.
Finally, a detailed description will be provided regarding the correlation between these HBV genetic molecular features and demographic distribution, clinical phases, and various clinical outcome events.
Read the detailed description
To identify HBV genotypes, viral integration, drug resistance, and molecular characteristics of mutations associated with clinical immune phases and different clinical outcome events based on a representative hepatitis B clinical cohort.
- Conditions
- Chronic Hepatitis B
- Keywords
- HBV, HBV Mutation, HBV Integration, HBV Resistance
- Medical subject headings
- Hepatitis B, Chronic
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 |
|---|---|---|
| Antiviral treatment chronic hepatitis B cohort | Not described | |
| Hepatitis B patients in cross-sectional epidemiological survey cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hepatitis B virus integration sites and count under antiviral treatment
Measured: Testing of previously collected samples within the time frame of 2015 to 2023
Secondary outcomes (3)
Hepatitis B virus variants related to drug resistance under antiviral treatment
Measured: Testing of previously collected samples within the time frame of 2015 to 2023
Genetic mutations in Hepatitis B virus across different regions and populations.
Measured: Testing of previously collected samples within the time frame of 2014 to 2023
Genetic mutations in Hepatitis B virus related to different stages of disease progression
Measured: Testing of previously collected samples within the time frame of 2015 to 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Feb 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong You, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779864
- Sponsor's protocol ID
- 2023YFC2306903
- Acronym
- HBV IMDR
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characteristics of Hepatitis B Virus Integration, Mutation, and Drug Resistance
- ClinicalTrials.gov ID
- NCT06779864
- Acronym / sponsor ID
- HBV IMDR / 2023YFC2306903
- Conditions
- Chronic Hepatitis B
- Keywords
- HBV, HBV Mutation, HBV Integration, HBV Resistance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 17 Jan 2025 (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.
Patients with a confirmed diagnosis of chronic hepatitis B (CHB) who have complete clinical data and retained blood or liver tissue samples will be enrolled. All patients will be grouped based on cohort sources: the Antiviral Treatment Cohort and the Cross-Sectional Epidemiological Survey Cohort.
Patients in the Antiviral Treatment Cohort have received antiviral treatment and are followed every six months. During follow-up, HBV-related endpoint events, including cirrhosis decompensations (such as ascites, esophageal variceal bleeding, and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplantation, and liver-related death, will be collected.
In the Cross-Sectional Epidemiological Survey Cohort, clinical data will be collected at a single time point, with some patients not receiving antiviral treatment.
In both cohorts, retained blood and liver tissue samples will be used to further analyze HBV genotypes, viral integration, drug resistance, and the molecular characteristics of mutations.
Finally, a detailed description will be provided regarding the correlation between these HBV genetic molecular features and demographic distribution, clinical phases, and various clinical outcome events.
Detailed description
To identify HBV genotypes, viral integration, drug resistance, and molecular characteristics of mutations associated with clinical immune phases and different clinical outcome events based on a representative hepatitis B clinical cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antiviral treatment chronic hepatitis B cohort | – | – |
| Hepatitis B patients in cross-sectional epidemiological survey cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatitis B surface antigen positive, who have complete clinical data and retained blood samples or liver tissue samples.
Key inclusion criteria (2 listed)
- Patients with hepatitis B surface antigen positive.
- Patients who have complete demographic information, clinical data and retained blood samples or liver tissue samples
Key exclusion criteria (1 listed)
- Subject who without blood samples or liver tissue samples
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
Changes in hepatitis B virus integration sites and count under antiviral treatment
Time frame: Testing of previously collected samples within the time frame of 2015 to 2023
3 secondary outcomes
Hepatitis B virus variants related to drug resistance under antiviral treatment
Time frame: Testing of previously collected samples within the time frame of 2015 to 2023
Genetic mutations in Hepatitis B virus across different regions and populations.
Time frame: Testing of previously collected samples within the time frame of 2014 to 2023
Genetic mutations in Hepatitis B virus related to different stages of disease progression
Time frame: Testing of previously collected samples within the time frame of 2015 to 2023
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No
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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.
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 Chronic Hepatitis B, run by Beijing Friendship Hospital 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 2 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: looking for participants now, as of the sponsor's last update on 17 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoning Wu (86+(010)6313-8665, byfriendship145@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in hepatitis B virus integration sites and count under antiviral treatment (time frame: Testing of previously collected samples within the time frame of 2015 to 2023). 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 17 Jan 2025.