Chronic Hepatitis BNCT07865520
Alcohol Consumption and Plasma cfDNA Methylation in Chronic Hepatitis B
An observational study of Chronic Hepatitis B and Alcoholic Hepatitis, run by Beijing Municipal Administration of Hospitals at 1 site in China.
Trial summary
This is an observational, exploratory study designed to investigate the effect of different levels of alcohol consumption on plasma cell-free DNA (cfDNA) methylation profiles in participants with chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 30 to 74 years
- Conditions the study is for
- Chronic Hepatitis B, Alcoholic Hepatitis
- What is being tested?
- Alcohol Consumption
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2025to 31 May 2026
- 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 30 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of participants with chronic hepatitis B. Participants are grouped according to alcohol consumption status into a non-drinking group, a drinking group, and a group that has developed alcoholic hepatitis associated with alcohol consumption.
Who may be able to join
- Age ≥30 years and <75 years.
- Diagnosed with chronic hepatitis B.
- Able and willing to provide written informed consent and comply with study sampling and assessments.
Who cannot join
- Liver cirrhosis.
- Pregnant or breastfeeding women.
- History of cancer or presence of cancer at screening.
- History of severe acute infectious disease within 14 days before screening, such as severe or critical COVID-19 or sepsis.
- Use of any of the following medications within 14 days before screening: intravenous or oral glucocorticoids; intravenous or oral azacitidine, decitabine, procainamide, hydralazine, or arsenic trioxide.
- Previous organ transplantation, bone marrow transplantation, or stem cell transplantation, or blood transfusion within 30 days before screening.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015
About this study
Official title: A Preliminary Exploration of the Effect of Alcohol Consumption on Plasma Cell-Free DNA Methylation Profiles in Participants With Chronic Hepatitis B
This is an observational, exploratory study designed to investigate the effect of different levels of alcohol consumption on plasma cell-free DNA (cfDNA) methylation profiles in participants with chronic hepatitis B. A total of 85 participants with chronic hepatitis B are planned to be enrolled and grouped according to their alcohol consumption status into a non-drinking group, a drinking group, and a group with alcoholic hepatitis associated with alcohol consumption. Approximately 16 mL of peripheral blood will be collected from each participant for cfDNA methylation analysis. Plasma cfDNA methylation profiles will be compared among participants with different levels of alcohol consumption to explore the effects of alcohol consumption on cfDNA methylation.
Read the detailed description
This observational, exploratory study aims to preliminarily investigate differences in plasma cell-free DNA (cfDNA) methylation profiles among participants with chronic hepatitis B according to their level of alcohol consumption. No clinical therapeutic intervention will be administered as part of the study.
A total of 85 participants with chronic hepatitis B are planned to be enrolled. Participants will be grouped according to their alcohol consumption status into a non-drinking group, a drinking group, and a group with alcoholic hepatitis associated with alcohol consumption.
Approximately 16 mL of peripheral blood will be collected from each participant in two tubes (8 mL per tube) for cfDNA methylation analysis. Plasma cfDNA methylation profiles will be compared among participants with different levels of alcohol consumption to evaluate the effects of alcohol consumption on cfDNA methylation.
In addition, differential cfDNA methylation sites will be analyzed in relation to pathways associated with hepatic metabolism, inflammation, and apoptosis to explore the potential molecular mechanisms through which alcohol consumption affects cfDNA methylation in chronic hepatitis B.
- Conditions
- Chronic Hepatitis B, Alcoholic Hepatitis
- Being tested
- Alcohol Consumption
- Keywords
- Chronic Hepatitis B, Alcohol Consumption, Alcoholic Hepatitis, Cell-Free DNA
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis, Alcoholic, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol ConsumptionOther
Alcohol consumption status was assessed in participants with chronic hepatitis B. Participants were categorized according to their alcohol consumption status into a non-drinking group, a drinking group, and a group with alcoholic hepatitis associated with alcohol consumption.
| Study group | Role | What they receive |
|---|---|---|
| Non-Drinking Group | Participants with chronic hepatitis B who do not consume alcohol. | |
| Drinking Group | Participants with chronic hepatitis B who consume alcohol. Receives: Other: Alcohol Consumption | |
| Alcoholic Hepatitis Group | Participants with chronic hepatitis B who have developed alcoholic hepatitis associated with alcohol consumption. Receives: Other: Alcohol Consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma cfDNA Methylation Levels
Plasma cell-free DNA (cfDNA) methylation levels will be measured and compared among participants with chronic hepatitis B with different alcohol consumption status and participants with alcoholic hepatitis.
Measured: Day 1 (at the time of blood sample collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start21 Nov 2025
- Primary completion31 May 2026
- Study completion31 May 2026
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.
- 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Municipal Administration of Hospitals
- Sponsor type
- Other government
- Collaborators
- Qinghai Fourth People's Hospital, Peking University Shenzhen Hospital
- Responsible party
- Principal investigator, Minghui Li, Beijing Municipal Administration of Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865520
- Sponsor's protocol ID
- DTEC-KY2025-138-01
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Exploration of the Effect of Alcohol Consumption on Plasma Cell-Free DNA Methylation Profiles in Participants With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT07865520
- Acronym / sponsor ID
- DTEC-KY2025-138-01
- Conditions
- Chronic Hepatitis B, Alcoholic Hepatitis
- Keywords
- Chronic Hepatitis B, Alcohol Consumption, Alcoholic Hepatitis, Cell-Free DNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Beijing Municipal Administration of HospitalsOther government
- Collaborators
- Qinghai Fourth People's Hospital, Peking University Shenzhen Hospital
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 8 Oct 2026 (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 is an observational, exploratory study designed to investigate the effect of different levels of alcohol consumption on plasma cell-free DNA (cfDNA) methylation profiles in participants with chronic hepatitis B. A total of 85 participants with chronic hepatitis B are planned to be enrolled and grouped according to their alcohol consumption status into a non-drinking group, a drinking group, and a group with alcoholic hepatitis associated with alcohol consumption. Approximately 16 mL of peripheral blood will be collected from each participant for cfDNA methylation analysis. Plasma cfDNA methylation profiles will be compared among participants with different levels of alcohol consumption to explore the effects of alcohol consumption on cfDNA methylation.
Detailed description
This observational, exploratory study aims to preliminarily investigate differences in plasma cell-free DNA (cfDNA) methylation profiles among participants with chronic hepatitis B according to their level of alcohol consumption. No clinical therapeutic intervention will be administered as part of the study.
A total of 85 participants with chronic hepatitis B are planned to be enrolled. Participants will be grouped according to their alcohol consumption status into a non-drinking group, a drinking group, and a group with alcoholic hepatitis associated with alcohol consumption.
Approximately 16 mL of peripheral blood will be collected from each participant in two tubes (8 mL per tube) for cfDNA methylation analysis. Plasma cfDNA methylation profiles will be compared among participants with different levels of alcohol consumption to evaluate the effects of alcohol consumption on cfDNA methylation.
In addition, differential cfDNA methylation sites will be analyzed in relation to pathways associated with hepatic metabolism, inflammation, and apoptosis to explore the potential molecular mechanisms through which alcohol consumption affects cfDNA methylation in chronic hepatitis B.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Drinking Group | – | –Participants with chronic hepatitis B who do not consume alcohol. |
| Drinking Group | – | Other: Alcohol ConsumptionParticipants with chronic hepatitis B who consume alcohol. |
| Alcoholic Hepatitis Group | – | Other: Alcohol ConsumptionParticipants with chronic hepatitis B who have developed alcoholic hepatitis associated with alcohol consumption. |
Who may qualify
- Ages
- 30 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of participants with chronic hepatitis B. Participants are grouped according to alcohol consumption status into a non-drinking group, a drinking group, and a group that has developed alcoholic hepatitis associated with alcohol consumption.
Key inclusion criteria (3 listed)
- Age ≥30 years and <75 years.
- Diagnosed with chronic hepatitis B.
- Able and willing to provide written informed consent and comply with study sampling and assessments.
Key exclusion criteria (7 listed)
- Liver cirrhosis.
- Pregnant or breastfeeding women.
- History of cancer or presence of cancer at screening.
- History of severe acute infectious disease within 14 days before screening, such as severe or critical COVID-19 or sepsis.
- Use of any of the following medications within 14 days before screening: intravenous or oral glucocorticoids; intravenous or oral azacitidine, decitabine, procainamide, hydralazine, or arsenic trioxide.
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 |
|---|---|---|
| Alcohol ConsumptionAlcohol consumption status was assessed in participants with chronic hepatitis B. Participants were categorized according to their alcohol consumption status into a non-drinking group, a drinking group, and a group with alcoholic hepatitis associated with alcohol consumption. | Other | Alcoholic Hepatitis Group, Drinking Group |
Primary outcome
Plasma cfDNA Methylation Levels
Time frame: Day 1 (at the time of blood sample collection)
Plasma cell-free DNA (cfDNA) methylation levels will be measured and compared among participants with chronic hepatitis B with different alcohol consumption status and participants with alcoholic hepatitis.
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 Oct 2026.
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Chronic 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Alcoholic Hepatitis, run by Beijing Municipal Administration of Hospitals 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 3 inclusion and 7 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 Oct 2026. 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?
Plasma cfDNA Methylation Levels (time frame: Day 1 (at the time of blood sample collection)). 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 8 Oct 2026.