Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372990
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-15
Brief Title:
Rapid T-cell Analysis Test in Patients With Chronic HBV and HBVHDV Disease
Sponsor:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Organization:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Study Overview
Official Title:
Development of a Rapid T-cell Analysis Test to Guide the Management of Patients With Chronic HBV and HBVHDV Disease
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BDTc
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 andor 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 WP11 - Clinical and virological phenotyping of CHB and CHD patients WP12 - Clinical evaluation of rapid HBV T cell test in CHB and CHD populations
WP 2 Singapore team WP21 - Applicability of the rapid T cell assay approach WP 22 - 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
The study design allows longitudinal evaluation of the immune response during the natural history of the infection andor 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 WP11 - Clinical and virological phenotyping of CHB and CHD patients WP12 - Clinical evaluation of rapid HBV T cell test in CHB and CHD populations
WP 2 Singapore team WP21 - Applicability of the rapid T cell assay approach WP 22 - 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None