About this trial
Prospective, non-pharmacological, single-center, non-profit observational study.
The study design allows longitudinal evaluation of the immune response during the natural history of the infection and/or treatment, correlating the data with the outcome of the disease and antiviral therapies, which will be collected as study variables from the source documents.
The study population will be patients suffering from chronic HBV infection with or without HBV-HDV co-infection followed at the Division of Gastroenterology and Hepatology of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico.
The present study is part of an international cooperation project between the Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy) and the Duke-NUS Medical School, Singapore, financed by a grant (project MAECI-2023-23683653) and divided into two specific Work Packages:
* WP 1 Milan team (WP1.1 - Clinical and virological phenotyping of CHB and CHD patients; WP1.2 - Clinical evaluation of rapid HBV T cell test in CHB and CHD populations) * WP 2 Singapore team (WP2.1 - Applicability of the rapid T cell assay approach; WP 2.2 - Optimization of the rapid T cell assay protocol)
The primary objective of the study is to define the prevalence of specific T cell responses in patients with chronic HBV and HBV-HDV infection, through the application of a specific rapid T cell assay.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Co-infection with other hepatotropic viruses (HCV, HIV)
Treatment with immunosuppressive/immunomodulatory drugs
Other congenital and/or acquired immunodeficiency conditions
Trial population
The study will enrol patients with chronic HBV infection (defined by HBsAg antigen positivity for at least 6 months) with or without HBV-HDV co-infection (defined by HDV RNA positivity for at least 6 months) who meet the inclusion criteria and do not present any exclusion criteria.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Define the prevalence of specific T cell responses in patients with chronic HBV and HBV-HDV infection, through the application of a specific rapid T cell assay
prevalence of HBV- and HDV-specific T cell responses in patients with chronic HBV infection with or without HBV-HDV co-infection
Secondary outcomes
Evaluate differences in terms of T cell response in patients with chronic HBV infection vs. HBV-HDV
differences in terms of T cell response in HBV vs. HBV-HDV
Correlate the T cell response phenotype with the clinical profile (chronic infection vs. chronic hepatitis), disease severity (cirrhosis vs. non-cirrhosis) and response to specific HBV and HBV-HDV therapies
correlation of the T cell response phenotype with the clinical profile (chronic infection vs. chronic hepatitis) and disease severity (cirrhosis vs. non-cirrhosis)
Improve the rapid T cell analysis protocol by simplifying the process, reducing analysis time and/or reducing the amount of material (blood) needed
development and optimization of a rapid method for performing immunological assays
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead sponsor
Duke-NUS Graduate Medical School
Collaborator