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| Name | Class |
|---|---|
| Duke-NUS Graduate Medical School | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBV |
| ||
| HBV/HDV |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an average of 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an average of 2 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. | Recruiting | Milan | MI | 20122 | Italy |
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plasma
correlation of the T cell response phenotype with the clinical profile (chronic infection vs. chronic hepatitis) and disease severity (cirrhosis vs. non-cirrhosis) |
| through study completion, an average of 2 year |
| 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 | through study completion, an average of 2 year |