Chronic Hepatitis bNCT07684209
A Study on the Consistency Evaluation of Digital PCR Technology for Quantitative Detection of HBV Nucleic Acid
An observational study of Chronic Hepatitis b, run by Beijing Municipal Administration of Hospitals at 1 site in China.
Trial summary
The research plan aims to evaluate the consistency of the digital PCR-based hepatitis B virus nucleic acid quantification technique with the existing Roche qPCR-based detection method. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- the results were classified according to concentration levels
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 1 Aug 2028
- 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: 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.
Who may be able to join
- 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;
- Remaining samples (serum) that have undergone combas HBV DNA testing and have clear test results, with the sample collection time frozen for ≤ 6 months;
- The remaining sample volume is sufficient (≥ 1.0 mL), sufficient for digital PCR testing and necessary duplicate testing;
- Samples from the same patient at different time points can be included as independent samples, but the sampling interval time needs to be recorded.
Who cannot join
- Combine other liver virus infections such as HCV, HDV or HIV;
- Poor sample quality, such as severe hemolysis, lipemia or repeated freezing and thawing ≥ 3 times;
- The samples were not properly frozen and stored (-80℃) after collection or the temperature records were missing;
- The clinical information is severely lacking, making it impossible to confirm the diagnosis and treatment status;
- The duplicate samples already included at the same time point (only the first included sample is retained).
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
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015
About this study
Official title: A Study on the Consistency Evaluation of Digital PCR Technology for Quantitative Detection of Hepatitis B Virus Nucleic Acid
The research plan aims to evaluate the consistency of the digital PCR-based hepatitis B virus nucleic acid quantification technique with the existing Roche qPCR-based detection method. Approximately 200 samples of residual serum from patients with chronic hepatitis B, covering high, medium, low, and those below the Roche lower limit concentration or undetectable, will be collected. The two methods will be used for parallel testing. The main objective is to evaluate the quantitative consistency of the two methods within the quantifiable range of Roche (≥ 20 IU/mL); the secondary objectives include evaluating the qualitative detection rate of samples with concentrations below 20 IU/mL or undetectable nucleic acid.
Read the detailed description
The study aims to include a total sample size of approximately 200 cases: 100 positive cases: ≥ 1000 IU/mL: 40 cases; 100 - 1000 IU/mL: 30 cases; 20 - 100 IU/mL: 30 cases; 100 negative cases: lower than 20 IU/mL: 40 cases, and undetected: 60 cases. Collect the age, gender, duration of HBV infection, antiviral treatment drugs and treatment courses, HBeAg status, HBsAg quantification (if available), ALT/AST levels, date of blood sample collection, date and result of combas HBV DNA detection, and digital PCR detection results of the enrolled patients. By comparing the detection results of the two methods, evaluate the quantitative accuracy or qualitative detection ability of the digital PCR hepatitis B detection method.
- Conditions
- Chronic Hepatitis b
- Being tested
- the results were classified according to concentration levels
- Keywords
- Digital PCR, Chronic Hepatitis b, Combas TaqMan HBV DNA Test
- 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.
the results were classified according to concentration levelsOther
the results were classified according to concentration levels
| Study group | Role | What they receive |
|---|---|---|
| High-concentration group | After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group. Receives: Other: the results were classified according to concentration levels | |
| medium concentration group | After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group. Receives: Other: the results were classified according to concentration levels | |
| low concentration group | After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group. Receives: Other: the results were classified according to concentration levels | |
| extremely low concentration group | After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group. Receives: Other: the results were classified according to concentration levels | |
| undetectable group | After detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group. Receives: Other: the results were classified according to concentration levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantitative consistency
Evaluate the quantitative consistency of the self-developed digital PCR (ddPCR) method with the Roche Cobas TaqMan HBV DNA test (cobas HBV) within the quantifiable range (≥ 20 IU/mL)
Measured: "Baseline, single cross-sectional testing at sample collection, through study completion"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (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.
- 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
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Municipal Administration of Hospitals
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Minghui Li, Beijing Municipal Administration of Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684209
- Sponsor's protocol ID
- DTEC-KY2026-075-01
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Consistency Evaluation of Digital PCR Technology for Quantitative Detection of Hepatitis B Virus Nucleic Acid
- ClinicalTrials.gov ID
- NCT07684209
- Acronym / sponsor ID
- DTEC-KY2026-075-01
- Conditions
- Chronic Hepatitis b
- Keywords
- Digital PCR, Chronic Hepatitis b, Combas TaqMan HBV DNA Test
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Municipal Administration of HospitalsOther government
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 6 Jul 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.
The research plan aims to evaluate the consistency of the digital PCR-based hepatitis B virus nucleic acid quantification technique with the existing Roche qPCR-based detection method. Approximately 200 samples of residual serum from patients with chronic hepatitis B, covering high, medium, low, and those below the Roche lower limit concentration or undetectable, will be collected. The two methods will be used for parallel testing. The main objective is to evaluate the quantitative consistency of the two methods within the quantifiable range of Roche (≥ 20 IU/mL); the secondary objectives include evaluating the qualitative detection rate of samples with concentrations below 20 IU/mL or undetectable nucleic acid.
Detailed description
The study aims to include a total sample size of approximately 200 cases: 100 positive cases: ≥ 1000 IU/mL: 40 cases; 100 - 1000 IU/mL: 30 cases; 20 - 100 IU/mL: 30 cases; 100 negative cases: lower than 20 IU/mL: 40 cases, and undetected: 60 cases. Collect the age, gender, duration of HBV infection, antiviral treatment drugs and treatment courses, HBeAg status, HBsAg quantification (if available), ALT/AST levels, date of blood sample collection, date and result of combas HBV DNA detection, and digital PCR detection results of the enrolled patients. By comparing the detection results of the two methods, evaluate the quantitative accuracy or qualitative detection ability of the digital PCR hepatitis B detection method.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| High-concentration group | – | Other: the results were classified according to concentration levelsAfter detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group. |
| medium concentration group | – | Other: the results were classified according to concentration levelsAfter detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group. |
| low concentration group | – | Other: the results were classified according to concentration levelsAfter detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group. |
| extremely low concentration group | – | Other: the results were classified according to concentration levelsAfter detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group. |
| undetectable group | – | Other: the results were classified according to concentration levelsAfter detection using digital PCR technology, the results were classified according to concentration levels as follows: high concentration group (≥ 1000 IU/mL); medium concentration group (100 - 1000 IU/mL); low concentration group (20 - 100 IU/mL); extremely low concentration group (below 20 IU/mL); undetectable group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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;
- Remaining samples (serum) that have undergone combas HBV DNA testing and have clear test results, with the sample collection time frozen for ≤ 6 months;
- The remaining sample volume is sufficient (≥ 1.0 mL), sufficient for digital PCR testing and necessary duplicate testing;
- Samples from the same patient at different time points can be included as independent samples, but the sampling interval time needs to be recorded.
Key exclusion criteria (5 listed)
- Combine other liver virus infections such as HCV, HDV or HIV;
- Poor sample quality, such as severe hemolysis, lipemia or repeated freezing and thawing ≥ 3 times;
- The samples were not properly frozen and stored (-80℃) after collection or the temperature records were missing;
- The clinical information is severely lacking, making it impossible to confirm the diagnosis and treatment status;
- The duplicate samples already included at the same time point (only the first included sample is retained).
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 |
|---|---|---|
| the results were classified according to concentration levelsthe results were classified according to concentration levels | Other | High-concentration group, extremely low concentration group, low concentration group, medium concentration group, undetectable group |
Primary outcome
quantitative consistency
Time frame: "Baseline, single cross-sectional testing at sample collection, through study completion"
Evaluate the quantitative consistency of the self-developed digital PCR (ddPCR) method with the Roche Cobas TaqMan HBV DNA test (cobas HBV) within the quantifiable range (≥ 20 IU/mL)
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 7 Jul 2026.
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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.
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, 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 7 Jul 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?
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?
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?
quantitative consistency (time frame: "Baseline, single cross-sectional testing at sample collection, through study completion"). 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 7 Jul 2026.