Recruiting NCT06372990

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

— Observational HBV HBV/HDV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: HBV, HBV/HDV. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Italy
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Primary outcome measures

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 [Time frame: through study completion, an average of 2 year]

Secondary outcome measures (3)

Evaluate differences in terms of T cell response in patients with chronic HBV infection vs. HBV-HDV [Time frame: 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 [Time frame: 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 [Time frame: through study completion, an average of 2 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Italy · 1 center

Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology an — Milan

Identifiers

NCT: NCT06372990 · 0015338

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗