Study of Immune Changes and Natural Progression in Chronic Hepatitis B Infection Following Patients Aged 1 to 80 Years Without Antiviral Treatment

What This Trial Is About

This research aims to follow patients with chronic hepatitis B virus HBV infection to understand how their immune system changes over time and how the infection naturally progresses as they age. It investigates whether changes in HBV-specific immune responses relate to the diseases course and how age influences these immune and disease changes. The study focuses on patients aged 1 to 80 years who have chronic HBV infection and have not received antiviral treatment recently. Patients will be observed without any additional treatment beyond their usual care, following them every six months for at least six visits. During each visit, blood samples will be taken to analyze the immune cells related to HBV, including specific T and B cells. Standard clinical tests such as HBV viral load, surface antigen, e antigen, and antibodies will also be performed, alongside other tests like alpha-fetoprotein and liver stiffness scans as needed. Blood volumes collected differ by age, with adults providing 30 ml and minors 6 ml at each visit. Participants will provide routine medical information including medical history, physical examinations, and laboratory results collected through their usual clinical care. Researchers will monitor immune responses and disease markers over a five-year follow-up period. Safety is overseen by tracking any adverse events or serious health issues that arise during the study. Data privacy is maintained by using unique participant IDs, and patients may withdraw at any time. The total participation duration may extend up to many years as long-term follow-up continues.

Immune Dynamics in the Natural History of Chronic HBV Infection