European Registry for Patients with Chronic Hepatitis B Virus Infection to Support Future Immunotherapy Studies

What this Trial Is About

Researchers are establishing a European-wide registry to study patients with chronic hepatitis B virus HBV infection, including those with HBV mono- and co-infections. This registry aims to analyze virus and host-specific factors in these patients, providing important information to better understand HBV control and help classify patients for future immunomodulatory therapy trials. The project also seeks to identify hepatitis B patients interested in participating in upcoming studies focused on immunotherapies such as therapeutic vaccines. The study involves no interventions or treatments but collects detailed clinical and laboratory data from participants. A subgroup called the TherVacB cohort includes patients with stricter inclusion criteria, such as documented chronic HBV infection and specific virological markers. This observational registry will monitor patients over time to gather information without altering their standard medical care. Participants will undergo evaluations including measurement of hepatitis B surface antigen HBsAg levels, seroconversion to anti-HBs antibodies, and quantification of immune markers like IL6, IP-10, IFNg, and IL1beta over five years. Additional assessments cover quality of life, liver health outcomes including cirrhosis and hepatocellular carcinoma, and survival related to hepatitis B. The study will help stratify patients for future clinical trials and improve understanding of HBV infection progression under real-world conditions.

A Non-interventional Registry for Patients with Hepatitis B Virus Infection