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Immunological and Virological Characterization of Patients With Chronic HBV-HDV Infection: Outcomes and Response to Bulevirtide Treatment

Recruitingn/aAges 18 Years - anyAllFondazione IRCCS Ca' Granda, Ospedale Maggiore Po…
NCT06504485 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 im

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📋 Eligibility rules (as published)
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
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What it tests

  • Bulevirtide
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Where

1 site
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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