Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment
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
- The protocol lists: Bulevirtide.
- Who it may be relevant to
- Registry conditions: Hepatitis D. 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
Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Association With Disease Outcomes and Response to Bulevirtide Treatment
Overview
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).
Interventions
- Drug Bulevirtide
dose of 2 mg/day subcutaneously
Primary outcome measures
- Calculate the prevalence of HDV-specific T responses in patients with chronic HBV-HDV infection naïve to treatment with Bulevirtide [Time frame: through study completion, an average of 2 year]
- 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) [Time frame: Month 12]
Secondary outcome measures (12)
- Correlate HDV-specific T cell response with stage of liver disease [Time frame: through study completion, an average of 2 year]
- Analyze the role of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) in predicting the stage of liver disease [Time frame: through study completion, an average of 2 year]
- Correlate the quantification of HDV RNA within exosomes with the stage of liver disease [Time frame: through study completion, an average of 2 year]
- Investigate the correlation between the genetic heritage of HDV and the stage of liver disease [Time frame: through study completion, an average of 2 year]
- Define the transcriptional and molecular signatures of CD8 T cell dysfunction in patients with chronic HBV/HDV coinfection [Time frame: through study completion, an average of 2 year]
- Understanding the role of virus mutations in the virus's ability to escape CD8 T cell surveillance [Time frame: through study completion, an average of 2 year]
- Correlate the prevalence of HDV-specific T cell responses with response to treatment over time [Time frame: Month 6]
- Correlate the prevalence of HDV-specific T cell responses with response to treatment over time [Time frame: Month 18]
- Correlate the prevalence of HDV-specific T cell responses with response to treatment over time [Time frame: through study completion, an average of 2 year]
- Analyze the role of new HBV serum biomarkers (HBcrAg, HBV RNA, HBsAg isoforms) in predicting response to treatment with Bulevirtide; [Time frame: through study completion, an average of 2 year]
- Correlate quantification of HDV RNA within exosomes with response to Bulevirtide treatment [Time frame: through study completion, an average of 2 year]
- Investigate the correlation between the genetic heritage of HDV and the response to treatment with Bulevirtide [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 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
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: NCT06504485 · P2022WEXP2