Hepatitis BNCT07637214
A Real-world Study: Analysis of the Efficacy of Antiviral Therapy in CHB Patients Over 30 Years Old, HBV DNA Positive and ALT Normal
An observational study of Hepatitis B and Chronic, run by Tongji Hospital at 1 site in China.
Trial summary
This is a prospective observational study of CHB patients who have not received antiviral treatment but HBV DNA are positive.Investigators aim to explore the antiviral effect and influencing factors of patients over 30 years old with normal ALT level after receiving antiviral treatment. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Chronic, Treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2023to 13 Jun 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The research population is CHB patients who have never received antiviral treatment and come to Tongji hospital for consultation and reexamination.
Who may be able to join
- CHB patients over 30 years old ；
- HBV DNA >20IU/ml and ALT level ≤40U/L；
- All of them have never received any antiviral treatment(including NAs and interferon-α）。
Who cannot join
- pregnancy status;
- Patients with compensated/decompensated cirrhosis and liver cancer have been diagnosed by imaging or other indicators;
- HCV, HIV, EB virus/cytomegalovirus infection, schistosomiasis liver disease, drug-induced liver injury, autoimmune hepatitis and alcoholic liver disease;
- Use immunosuppressants ;
- Previous history of liver cancer, organ transplantation and alcoholism (male ≥30 g/d, female ≥20 g/d);
- Insufficient follow-up time and imperfect clinical/laboratory informations;
- Combined with other major diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Curative Effect Analysis of Antiviral Therapy in CHB Patients Over 30 Years Old With HBV DNA Positive and Normal ALT
This is a prospective observational study of CHB patients who have not received antiviral treatment but HBV DNA are positive.Investigators aim to explore the antiviral effect and influencing factors of patients over 30 years old with normal ALT level after receiving antiviral treatment.
Read the detailed description
In the past, clinicians thought that patients with chronic hepatitis B with normal ALT should be followed up regularly and not be treated with antiviral therapy for the time being, but more and more studies show that if antiviral therapy is not started in time, these patients still have a relatively high risk of cirrhosis and HCC. Therefore, the current Chinese guideline recommends that patients over the age of 30 with HBV DNA positive need antiviral treatment even if their ALT levels are normal. In this study, investigators aim to observe the antiviral effect of CHB patients above 30 years old and normal liver function. CHB patients were divided into NAs （TMF, ETV, or TAF) treatment and untreated groups for follow-up. Then, participants who achieved HBV DNA negative and HBsAg <3000 IU/ml after 12 weeks of NAs therapy could choose either NAs combined with 48 weeks of pegylated interferon α-2b(Peg-IFNα-2b) therapy or continue NAs monotherapy. Follow-ups were conducted every 12-24 weeks for a total duration of 96 weeks. Dynamic observations included monitoring virological markers,biochemical indicators,liver stiffness measurement(LSM),and controlled attenuation parameter(CAP) throughout the study period. After obtaining the informed consent of participants, the serum of participants and PBMC of some participants were collected for further study,so that investigators are able to explore the serological indexes related to curative effect and the immune function of participants before and after treatment.
- Conditions
- Hepatitis B, Chronic, Treatment
- Keywords
- CHB, antiviral treatment
- Medical subject headings
- Hepatitis B, Bronchiolitis Obliterans Syndrome
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 |
|---|---|---|
| NA treatment | NA treated with TDF，ETV OR TMF | |
| Control group without antiviral treatment | Control group without antiviral treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
48-week HBV DNA negativity rate(%)
HBV DNA negative rate(%) at 48 weeks
Measured: 48 weeks
Secondary outcomes (1)
48-week ALT normalization rate(%)
ALT normalization rate(%) at 48 weeks
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start13 Mar 2023
- Primary completion13 Mar 2024
- Study completion13 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meifang Han, Tongji Hospital
- Investigators
- Meifang Han, Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637214
- Sponsor's protocol ID
- ALTN
- Status last verified
- Jun 2026
- First submitted
- 13 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curative Effect Analysis of Antiviral Therapy in CHB Patients Over 30 Years Old With HBV DNA Positive and Normal ALT
- ClinicalTrials.gov ID
- NCT07637214
- Acronym / sponsor ID
- ALTN
- Conditions
- Hepatitis B, Chronic, Treatment
- Keywords
- CHB, antiviral treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 9 Jun 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 a prospective observational study of CHB patients who have not received antiviral treatment but HBV DNA are positive.Investigators aim to explore the antiviral effect and influencing factors of patients over 30 years old with normal ALT level after receiving antiviral treatment.
Detailed description
In the past, clinicians thought that patients with chronic hepatitis B with normal ALT should be followed up regularly and not be treated with antiviral therapy for the time being, but more and more studies show that if antiviral therapy is not started in time, these patients still have a relatively high risk of cirrhosis and HCC. Therefore, the current Chinese guideline recommends that patients over the age of 30 with HBV DNA positive need antiviral treatment even if their ALT levels are normal. In this study, investigators aim to observe the antiviral effect of CHB patients above 30 years old and normal liver function. CHB patients were divided into NAs （TMF, ETV, or TAF) treatment and untreated groups for follow-up. Then, participants who achieved HBV DNA negative and HBsAg <3000 IU/ml after 12 weeks of NAs therapy could choose either NAs combined with 48 weeks of pegylated interferon α-2b(Peg-IFNα-2b) therapy or continue NAs monotherapy. Follow-ups were conducted every 12-24 weeks for a total duration of 96 weeks. Dynamic observations included monitoring virological markers,biochemical indicators,liver stiffness measurement(LSM),and controlled attenuation parameter(CAP) throughout the study period. After obtaining the informed consent of participants, the serum of participants and PBMC of some participants were collected for further study,so that investigators are able to explore the serological indexes related to curative effect and the immune function of participants before and after treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NA treatment | – | –NA treated with TDF，ETV OR TMF |
| Control group without antiviral treatment | – | –Control group without antiviral treatment |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The research population is CHB patients who have never received antiviral treatment and come to Tongji hospital for consultation and reexamination.
Key inclusion criteria (3 listed)
- CHB patients over 30 years old ；
- HBV DNA >20IU/ml and ALT level ≤40U/L；
- All of them have never received any antiviral treatment(including NAs and interferon-α）。
Key exclusion criteria (7 listed)
- pregnancy status;
- Patients with compensated/decompensated cirrhosis and liver cancer have been diagnosed by imaging or other indicators;
- HCV, HIV, EB virus/cytomegalovirus infection, schistosomiasis liver disease, drug-induced liver injury, autoimmune hepatitis and alcoholic liver disease;
- Use immunosuppressants ;
- Previous history of liver cancer, organ transplantation and alcoholism (male ≥30 g/d, female ≥20 g/d);
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
48-week HBV DNA negativity rate(%)
Time frame: 48 weeks
HBV DNA negative rate(%) at 48 weeks
1 secondary outcome
48-week ALT normalization rate(%)
Time frame: 48 weeks
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 9 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Meifang Han, Doctor principal investigator
Tongji Hospital
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 Hepatitis B and Chronic, run by Tongji 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 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 9 Jun 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?
48-week HBV DNA negativity rate(%) (time frame: 48 weeks). 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 9 Jun 2026.