Hurtig T-celleanalysetest hos patienter med kronisk HBV og HBV/HDV sygdom (BDTc)
Udvikling af en hurtig T-celleanalysetest til vejledning i behandlingen af patienter med kronisk HBV og HBV/HDV sygdom
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.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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MI
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Milan, MI, Italien, 20122
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
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HBV
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HBV/HDV
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: through study completion, an average of 2 year
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Evaluate differences in terms of T cell response in patients with chronic HBV infection vs. HBV-HDV
Tidsramme: through study completion, an average of 2 year
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differences in terms of T cell response in HBV vs. HBV-HDV |
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
Tidsramme: through study completion, an average of 2 year
|
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
|
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Improve the rapid T cell analysis protocol by simplifying the process, reducing analysis time and/or reducing the amount of material (blood) needed
Tidsramme: through study completion, an average of 2 year
|
development and optimization of a rapid method for performing immunological assays |
through study completion, an average of 2 year
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 0015338
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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