Immunologische und virologische Charakterisierung von Patienten mit chronischer HBV-HDV-Infektion: Ergebnisse und Reaktion auf die Behandlung mit Bulevirtid (MPR_BD)
Immunologische und virologische Charakterisierung von Patienten mit chronischer HBV-HDV-Infektion: Zusammenhang mit Krankheitsergebnissen und Reaktion auf die Behandlung mit Bulevirtid
Pharmacological, single-center, non-profit observational study.
The present study is part of a cooperation project between the SC Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy), the University of Milan, the University of Parma and Rome Tor Vergata, funded under the call for Research Projects of Significant National Interest - 2022 PNRR Call (Prot. P2022WEXP2).
Hepatitis D virus (HDV) is a defective RNA virus, which requires the presence of hepatitis B virus (HBV) to infect liver cells and propagate. To date, the mechanisms underlying the accelerated disease progression in the natural history of Delta hepatitis are poorly understood, as is the course of the HDV-specific immune response (CD4 and CD8 T cells). As in chronic HBV and HCV infections, the outcome of chronic HDV infection appears to be dictated primarily by the host immune response, which represents a key determinant for virus control or persistence. For HBV/HDV coinfection, the role of T cells has not been well defined, as suitable animal models are lacking and so far few HDV-specific T cell epitopes have been precisely mapped, mainly limited to HLA-B alleles.
The study is divided into two substudies (cross-sectional and longitudinal). The primary objective of the cross-sectional study is to calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide. The primary objective of the longitudinal study is the change in the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection during treatment with Bulevirtide compared to baseline (pre-treatment).
Studienübersicht
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Milan, Italien, 20122
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
The study will enroll patients co-infected with HBV-HDV (defined by positivity of HDV RNA for at least 6 months) who meet the inclusion criteria and no exclusion criteria
Beschreibung
Inclusion Criteria:
- 18 years of age or older
- Ability to understand and sign the informed consent
- Chronic HDV infection defined by positivity of HBsAg antigen (HBV) and HDV RNA (HBV-HDV co-infection) for at least 6 months at the time of enrollment.
Exclusion Criteria:
- Co-infection with other viruses (HCV, HIV)
- Treatment with immunosuppressive/immunomodulatory drugs
- Other congenital and/or acquired immunodeficiency conditions
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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Hepatis Delta naive
Patients with HDV infection naïve to Bulevirtide therapy |
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Hepatis Delta in therapy
Patients with HDV cirrhosis consecutively started on Bulevirtide therapy during the study enrollment period |
dose of 2 mg/day subcutaneously |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide
Zeitfenster: through study completion, an average of 2 year
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Prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide |
through study completion, an average of 2 year
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Change in the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection during treatment with Bulevirtide compared to baseline (pre-treatment)
Zeitfenster: Month 12
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Prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection after 12 months of treatment with Bulevirtide compared to baseline (pre-therapy) |
Month 12
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Correlate HDV-specific T cell response with stage of liver disease
Zeitfenster: through study completion, an average of 2 year
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Correlation of HDV-specific T cell response with stage of liver disease |
through study completion, an average of 2 year
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Analyze the role of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) in predicting the stage of liver disease
Zeitfenster: through study completion, an average of 2 year
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Quantification of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) and correlation with the stage of liver disease |
through study completion, an average of 2 year
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Correlate the quantification of HDV RNA within exosomes with the stage of liver disease
Zeitfenster: through study completion, an average of 2 year
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Correlation between the quantification of HDV RNA within exosomes and the disease phenotype |
through study completion, an average of 2 year
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Investigate the correlation between the genetic heritage of HDV and the stage of liver disease
Zeitfenster: through study completion, an average of 2 year
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Correlation between the genetic heritage of HDV and the stage of liver disease |
through study completion, an average of 2 year
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Define the transcriptional and molecular signatures of CD8 T cell dysfunction in patients with chronic HBV/HDV coinfection
Zeitfenster: through study completion, an average of 2 year
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Transcriptional and molecular signatures of CD8 T cell dysfunction in patients with chronic HBV/HDV coinfection |
through study completion, an average of 2 year
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Understanding the role of virus mutations in the virus's ability to escape CD8 T cell surveillance
Zeitfenster: through study completion, an average of 2 year
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Correlation between HDV mutations and the ability of the virus itself to escape CD8 T cell surveillance |
through study completion, an average of 2 year
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Correlate the prevalence of HDV-specific T cell responses with response to treatment over time
Zeitfenster: Month 6
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Correlation between the change in HDV-specific T responses |
Month 6
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Correlate the prevalence of HDV-specific T cell responses with response to treatment over time
Zeitfenster: Month 18
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Correlation between the change in HDV-specific T responses |
Month 18
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Correlate the prevalence of HDV-specific T cell responses with response to treatment over time
Zeitfenster: through study completion, an average of 2 year
|
Correlation between the change in HDV-specific T responses |
through study completion, an average of 2 year
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Analyze the role of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) in predicting response to treatment with Bulevirtide;
Zeitfenster: through study completion, an average of 2 year
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Quantification of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) and correlation with response to treatment with Bulevirtide |
through study completion, an average of 2 year
|
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Correlate quantification of HDV RNA within exosomes with response to Bulevirtide treatment
Zeitfenster: through study completion, an average of 2 year
|
Correlation between the quantification of HDV RNA within exosomes and the response to treatment with Bulevirtide |
through study completion, an average of 2 year
|
|
Investigate the correlation between the genetic heritage of HDV and the response to treatment with Bulevirtide
Zeitfenster: through study completion, an average of 2 year
|
Correlation between HDV genetic heritage and response to treatment with Bulevirtide |
through study completion, an average of 2 year
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P2022WEXP2
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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