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New DNA test could sharpen hepatitis b monitoring

NCT ID NCT07684209

Diagnosis Sponsor: Beijing Municipal Administration of Hospitals Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study compares a new, more precise digital PCR test with the standard test for measuring hepatitis B virus levels in people with chronic hepatitis B. Researchers will use leftover blood samples from about 200 patients to see if the new method matches the standard test's accuracy, especially for low virus levels. The goal is to find a better way to track the virus and guide treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the digital PCR method proves consistent with the standard test, it could offer a more precise and accessible way to monitor hepatitis B virus levels.
What could go wrong
This is a small, early-stage comparison study, not a treatment trial. The new method may not prove reliable enough to replace the existing test in clinical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The research samples were derived from the routine diagnostic leftover serum samples of chronic hepatitis B patients who were treated at the outpatient or inpatient departments of Beijing Ditan Hospital, Capital Medical University. All the samples were the leftover samples obtained after the routine HBV DNA testing (combas HBV) was completed, and they were the secondary utilization of the leftover samples from clinical routine tests.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients who have been diagnosed with chronic hepatitis B (in accordance with the diagnostic criteria of the "Chronic Hepatitis B Prevention and Treatment Guidelines (2022 Edition)") and are currently receiving NAs antiviral treatment for ≥ 6 months or have not received treatment and are ≥ 18 years old; 2. Remaining samples (serum) that have undergone combas HBV DNA testing and have clear test results, with the sample collection time frozen for ≤ 6 months; 3. The remaining sample volume is sufficient (≥ 1.0 mL), sufficient for digital PCR testing and necessary duplicate testing; 4. Samples from the same patient at different time points can be included as independent samples, but the sampling interval time needs to be recorded. Exclusion Criteria: 1. Combine other liver virus infections such as HCV, HDV or HIV; 2. Poor sample quality, such as severe hemolysis, lipemia or repeated freezing and thawing ≥ 3 times; 3. The samples were not properly frozen and stored (-80℃) after collection or the temperature records were missing; 4. The clinical information is severely lacking, making it impossible to confirm the diagnosis and treatment status; 5. The duplicate samples already included at the same time point (only the first included sample is retained).

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic hepatitis B

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Beijing Ditan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100015, China

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