Immune Dynamics in the Natural History of Chronic HBV Infection

Recruiting now

Conditions studied: HBV (Hepatitis B Virus), HBV Infection, Chronic Hep B

In brief

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.

Key facts

Study ID

NCT07137247

Run by

Nanfang Hospital, Southern Medical University

People needed

5000

Starts

2024-02-01

Expected to finish

2041-12-01

Last updated by the study team

2025-09-30

Who can join

Age: 1 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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…

• Concurrent Infections and Liver Diseases: Exclusion of patients with concurrent HCV or HIV infection, alcoholic fatty liver disease, non-alcoholic fatty liver disease, autoimmune liver diseases.
• Immune and Coagulation System Disorders: Exclusion of patients with immune system diseases such as hyperthyroidism, coagulation system disorders such as diabetes mellitus or idiopathic thrombocytopenic purpura.
• Severe Underlying Diseases. Exclusion of patients with severe underlying diseases that affect the body's immune status.
• Other Unsuitable Conditions:
• Exclusion of patients whom the investigator deems to have other conditions that make them unsuitable for enrollment.

Where it is running

• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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