Clinical trial NCT06372990: Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease
Official title: Development of a Rapid T-cell Analysis Test to Guide the Management of Patients With Chronic HBV and HBV/HDV Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HBV
HBV/HDV
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
Collaborators: name: Duke-NUS Graduate Medical School
First posted: 2024-04-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 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.


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

Primary outcomes:
measure: 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
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Evaluate differences in terms of T cell response in patients with chronic HBV infection vs. HBV-HDV
timeFrame: through study completion, an average of 2 year
measure: 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
timeFrame: through study completion, an average of 2 year
measure: Improve the rapid T cell analysis protocol by simplifying the process, reducing analysis time and/or reducing the amount of material (blood) needed
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
state: MI
Study officials:
References: