Actively Recruiting
Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2026-01-15
300
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
Sponsors
F
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead Sponsor
D
Duke-NUS Graduate Medical School
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Ability to understand and sign the informed consent
- Chronic HBV infection or HBV-HDV co-infection confirmed by positive HBsAg antigen (HBV) and HDV RNA (HBV-HDV co-infection) for at least 6 months
You will not qualify if you...
- Co-infection with other hepatotropic viruses such as HCV or HIV
- Treatment with immunosuppressive or immunomodulatory drugs
- Presence of other congenital or acquired immunodeficiency conditions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
Milan, MI, Italy, 20122
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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