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CompletedNCT07865520Updated Oct 8, 2026

Alcohol Consumption and Plasma cfDNA Methylation in Chronic Hepatitis B

An observational study in Chronic Hepatitis B and Alcoholic Hepatitis, sponsored by Beijing Municipal Administration of Hospitals. Completed at 1 site in China. Open to participants aged 30 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Beijing Municipal Administration of Hospitals · Observational

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
85
Ages
30 Years to 74 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Hepatitis B
  • Alcoholic Hepatitis

Keywords

  • Chronic Hepatitis B
  • Alcohol Consumption
  • Alcoholic Hepatitis
  • Cell-Free DNA
03

In context

Hepatitis B, Chronic

954 studies on the registry are indexed under Hepatitis B, Chronic; 147 are open to participants now.

This study's enrollment of 85 is below the median of 400 across 229 observational studies indexed under Hepatitis B, Chronic.

Browse Hepatitis B, Chronic studies →

Lead sponsor

Beijing Municipal Administration of Hospitals is the lead sponsor of 14 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥30 years and \<75 years.
  2. Diagnosed with chronic hepatitis B.
  3. Able and willing to provide written informed consent and comply with study sampling and assessments.

Exclusion criteria

Exclusion Criteria:

  1. Liver cirrhosis.
  2. Pregnant or breastfeeding women.
  3. History of cancer or presence of cancer at screening.
  4. History of severe acute infectious disease within 14 days before screening, such as severe or critical COVID-19 or sepsis.
  5. 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.
  6. Previous organ transplantation, bone marrow transplantation, or stem cell transplantation, or blood transfusion within 30 days before screening.
  7. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
85 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Non-Drinking Group

    Participants with chronic hepatitis B who do not consume alcohol.

  • Drinking Group

    Participants with chronic hepatitis B who consume alcohol.

    Other: Alcohol Consumption

  • Alcoholic Hepatitis Group

    Participants with chronic hepatitis B who have developed alcoholic hepatitis associated with alcohol consumption.

    Other: Alcohol Consumption

Interventions

  • OtherAlcohol Consumption

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1 (at the time of blood sample collection)

07

Study locations

1 site
  • Beijing Ditan Hospital, Capital Medical University
    Beijing, Beijing Municipality 100015, China
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07865520
Lead sponsor
Beijing Municipal Administration of Hospitals
Collaborators
Qinghai Fourth People's Hospital, Peking University Shenzhen Hospital
Responsible party
Minghui Li (Head of Department, Beijing Municipal Administration of Hospitals) — Principal investigator
First posted
Oct 8, 2026
Start date
Nov 21, 2025
Primary completion
May 31, 2026
Completion
May 31, 2026
Last update
Oct 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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