A Real-world Study: Analysis of the Efficacy of Antiviral Therapy in CHB Patients Over 30 Years Old, HBV DNA Positive and ALT Normal

Curative Effect Analysis of Antiviral Therapy in CHB Patients Over 30 Years Old With HBV DNA Positive and Normal ALT

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07637214

Enrollment

250

Registered

2026-06-09

Start date

2023-03-13

Completion date

2025-06-13

Last updated

2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic, Hepatitis B, Treatment

Keywords

CHB, antiviral treatment

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. CHB patients over 30 years old ； 2. HBV DNA \>20IU/ml and ALT level ≤40U/L； 3. All of them have never received any antiviral treatment(including NAs and interferon-α）。

Exclusion criteria

1. pregnancy status; 2. Patients with compensated/decompensated cirrhosis and liver cancer have been diagnosed by imaging or other indicators; 3. HCV, HIV, EB virus/cytomegalovirus infection, schistosomiasis liver disease, drug-induced liver injury, autoimmune hepatitis and alcoholic liver disease; 4. Use immunosuppressants ; 5. Previous history of liver cancer, organ transplantation and alcoholism (male ≥30 g/d, female ≥20 g/d); 6. Insufficient follow-up time and imperfect clinical/laboratory informations; 7. Combined with other major diseases.

Design outcomes

Primary

Measure	Time frame	Description
48-week HBV DNA negativity rate(%)	48 weeks	HBV DNA negative rate(%) at 48 weeks

Secondary

Measure	Time frame	Description
48-week ALT normalization rate(%)	48 weeks	ALT normalization rate(%) at 48 weeks

Countries

China

Contacts

PRINCIPAL_INVESTIGATORMeifang Han, Doctor

Tongji Hospital

Outcome results