Immune changes over time in people with chronic hepatitis B
Immune Dynamics in the Natural History of Chronic HBV Infection
Nanfang Hospital, Southern Medical University · NCT07137247
This project will follow untreated people aged 1–80 with chronic hepatitis B every six months to see if changes in HBV-specific immunity and age are linked to how the infection progresses.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 1 Year to 80 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07137247 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Untreated people aged 1–80 with a clinical diagnosis of chronic hepatitis B who have not received antiviral therapy in the past six months and can attend follow-ups at the study site.
Not a fit: People currently on antiviral therapy, those with concurrent HCV or HIV infection, significant liver comorbidities, systemic immune or coagulation disorders, or other severe underlying illnesses are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, the work could identify immune markers and age-related patterns that help time or design therapies aimed at achieving a functional cure for hepatitis B.
How similar studies have performed: Previous observational cohorts have described HBV-specific immune exhaustion and age-related immune differences, but clear causal links to long-term natural history and pathways to functional cure remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong
- Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Yongyin Li, Dr.
- Email: yongyinli@foxmail.com
- Phone: +8613826039505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HBV, HBV Infection, Chronic Hep B, HBV infection