HBV, HBV/HDV
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Duke-NUS Graduate Medical School
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | through study completion, an average of 2 year | prevalence of HBV- and HDV-specific T cell responses in patients with chronic HBV infection with or without HBV-HDV co-infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate differences in terms of T cell response in patients with chronic HBV infection vs. HBV-HDV | through study completion, an average of 2 year | 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 | through study completion, an average of 2 year | 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 | through study completion, an average of 2 year | development and optimization of a rapid method for performing immunological assays |
Countries
Italy
Outcome results
None listed