Immune changes over time in people with chronic hepatitis B

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort will enroll untreated patients aged 1–80 with chronic HBV infection and collect routine clinical, serological, and virological data at baseline and every six months. Peripheral blood samples will be taken at follow-up visits to measure HBV-specific humoral and cellular immune responses and characterize the broader immune environment. Investigators will compare immune cell generation, proliferation, and survival across patients at different immune-status stages to identify mechanisms of immune dysfunction. The protocol uses routine clinic visits with no extra mandatory procedures beyond venipuncture and chart review.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

• 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's running

• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yongyin Li, Dr.
• Email: yongyinli@foxmail.com
• Phone: +8613826039505

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.