Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease

HBV Clinical Trial

— BDTc  

Official title:

Development of a Rapid T-cell Analysis Test to Guide the Management of Patients With Chronic HBV and HBV/HDV Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06372990
• Other study ID #: 0015338
• Status: Recruiting
• Start date: April 15, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: April 2024
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HBV

Locations

Country	Name	City	State
Italy	Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.	Milano	MI

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Duke-NUS Medical School (Singapore)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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)	through study completion, an average of 2 year
Secondary	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