NCT07137247Recruiting
Immune Dynamics in the Natural History of Chronic HBV Infection
Source: ClinicalTrials.gov · Last updated 30 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 19 Jun 2025
- Start date
- 1 Feb 2024
- Primary completion date
- 1 Dec 2040
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Hepatitis B
- NCT number
- NCT07137247
What you commit to
- Study type: Observational
- Planned participants: 5000
- From 1 Feb 2024 to the primary completion date, 1 Dec 2040
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 1 year to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.