Immune Dynamics in the Natural History of Chronic HBV Infection

NCT07137247 | Recruiting

• 1 other identifier: NFEC-2021-216
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this observational study is to follow up on chronic HBV-infected patients over a long period of time to understand the changes in the immune status as age increases and the natural history of chronic HBV infection progresses. The main questions it aims to answer are:

• Does the natural history of chronic HBV infection progress with changes in HBV-specific immunity?
• What is the role of age in the natural history of chronic HBV infection? Patients with chronic HBV infection who are untreated and aged 1-80 years will be followed up every six months. During each follow-up, HBV-related serological and virological indicators will be tested. Peripheral blood samples will also be collected to test HBV-specific immunity and the immune environment.

Conditions

HBV (Hepatitis B Virus); HBV Infection; Chronic Hep B

Keywords

HBV; Chronic Hep B; HBV infection

Outcome Measures

Primary Outcomes (1)

• In accordance with the 2018 AASLD Hepatitis B guidelines, the natural history of HBV is staged based on the laboratory test results (HBV serological markers, viral load, and liver function) and imaging findings of the enrolled patients.

  Enrolled patients will undergo examinations of HBV serological markers, viral load, liver function, liver ultrasound, and liver fibrosis every six months. Subsequently, based on the 2018 AASLD Hepatitis B guidelines , patients will be staged to observe whether there are changes in the natural history of hepatitis B.

  over a follow-up period of 5 years

Secondary Outcomes (1)

• The HBV-specific immune response levels will be measured using the immune cells of the enrolled patients

  over a follow-up period of five years

Study Arms (1)

Chronic hepatitis B virus (HBV) infection

Patients with chronic HBV infection who are untreated and aged 1-80 years. Follow-ups will be conducted every six months, with a minimum of six visit points.

Procedure: Venipuncture

Interventions

Venipuncture PROCEDURE

For adults (including those who are 18 years old): During the routine follow-up visits, an extra 30 milliliters of peripheral blood will be drawn. For minors (under 18 years old): During the routine follow-up visits, an extra 6 milliliters of peripheral blood will be drawn. Follow-ups will be conducted every six months, with a minimum of six visit points.

Chronic hepatitis B virus (HBV) infection

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of chronic hepatitis B patients who have not received antiviral therapy within the past six months.

You may qualify if:

• Aged 1-80 years, either male or female.
• Patients diagnosed with chronic hepatitis B virus infection in accordance with the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B" (2019 edition).
• No antiviral treatment (including nucleoside analogs and interferons, etc.) within the past six months.

You may not qualify if:

• Other Unsuitable Conditions:

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B; Hepatitis B, Chronic

Interventions

Phlebotomy

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; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Yongyin Li, Dr.

CONTACT

+8613826039505; yongyinli@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: August 22, 2025
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2041
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)