Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease

Launched by FONDAZIONE IRCCS CA' GRANDA, OSPEDALE MAGGIORE POLICLINICO · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how the immune system responds in patients with chronic hepatitis B virus (HBV) infection, and those who have both HBV and hepatitis D virus (HBV/HDV) infection. Researchers want to understand the presence of specific immune cells called T cells and how these relate to the progression of the disease and the effectiveness of antiviral treatments. The study involves patients who are at least 18 years old and have been diagnosed with chronic HBV or HBV/HDV for at least six months. However, individuals with other liver infections or those on certain immune-suppressing medications will not be included.

Participants in the study will undergo a rapid T cell test to help define their immune response to the virus. The research is taking place at a hospital in Milan, Italy, and is part of an international collaboration with a medical school in Singapore. By participating, patients will contribute to understanding the immune response in these infections, which may lead to better treatments in the future. If you're interested in joining the study, you'll need to understand the details and sign a consent form, ensuring you know what to expect throughout the trial.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years of age or older
• • ability to understand and sign the informed consent
• • chronic HBV infection or HBV-HDV co-infection defined by positivity of HBsAg antigen (HBV) and HDV RNA (HBV-HDV co-infection) for at least 6 months
• Exclusion Criteria:
• • Co-infection with other hepatotropic viruses (HCV, HIV)
• • Treatment with immunosuppressive/immunomodulatory drugs
• • Other congenital and/or acquired immunodeficiency conditions