Test d'analyse rapide des lymphocytes T chez les patients atteints de la maladie chronique du VHB et du VHB/HDV (BDTc)
Développement d'un test d'analyse rapide des lymphocytes T pour guider la prise en charge des patients atteints de la maladie chronique du VHB et du VHB/HDV
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.
Aperçu de l'étude
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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MI
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Milan, MI, Italie, 20122
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
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HBV
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HBV/HDV
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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
Délai: through study completion, an average of 2 year
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Evaluate differences in terms of T cell response in patients with chronic HBV infection vs. HBV-HDV
Délai: 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
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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
Délai: through study completion, an average of 2 year
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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
Délai: through study completion, an average of 2 year
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development and optimization of a rapid method for performing immunological assays |
through study completion, an average of 2 year
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Collaborateurs et enquêteurs
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 0015338
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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