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

NCT07637214 | Completed

• 1 other identifier: ALTN
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic; Hepatitis B; Treatment

Keywords

CHB; antiviral treatment

Outcome Measures

Primary Outcomes (1)

• 48-week HBV DNA negativity rate(%)

  HBV DNA negative rate(%) at 48 weeks

  48 weeks

Secondary Outcomes (1)

• 48-week ALT normalization rate(%)

  48 weeks

Other Outcomes (1)

• Degree of improvement in liver fibrosis

  48 weeks

Study Arms (2)

NA treatment

NA treated with TDF，ETV OR TMF

Control group without antiviral treatment

Control group without antiviral treatment

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The research population is CHB patients who have never received antiviral treatment and come to Tongji hospital for consultation and reexamination.

You may qualify if:

• 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）。

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital,Wuhan,Hubei

Wuhan, Hubei, 430000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum and PBMCs

MeSH Terms

Conditions

Hepatitis B; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Meifang Han, Doctor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Department of Infectious Diseases

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: June 9, 2026
• Study Start: March 13, 2023
• Primary Completion: March 13, 2024
• Study Completion: June 13, 2025
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

CN (1)