"Referral Attivo" Delta, Dallo Screening Alla Presa in Carico.
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatitis, Delta. Basic parameters: 18 years — 100 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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Overview
The aim of the "Active Delta Referral" Project is to estimate the prevalence of anti-HDV positivity among HBsAg-positive patients hospitalized in the Department of Medicine at ASST Papa Giovanni XXIII in Bergamo, as well as among patients at the SerD and the Prison Healthcare Unit of the same ASST, following the introduction of the new methodology in 2025, and to compare these findings with existing estimates for outpatients.
Detailed description
Hepatitis Delta (HDV) is the most severe form of chronic viral hepatitis, associated with high morbidity and mortality, and affects only HBsAg-positive patients. Despite its severity, it remains largely underdiagnosed due to limited awareness among physicians and the absence of automatic screening. Current guidelines recommend testing all HBsAg-positive patients for anti-HDV, but in clinical practice this is rarely implemented.
The introduction of an "HDV-reflex" screening strategy, already successfully adopted in other countries, would allow for earlier identification of affected patients and improved clinical management, especially in light of the recent availability of new therapeutic options.
The HDV-reflex test will increase the number of patients screened for this virus, enabling an accurate estimate of HDV prevalence among HBV-positive individuals. It will also improve referral pathways and indications for antiviral treatment, and over time reduce the number of patients presenting at their first hepatology consultation with advanced HDV-related disease (such as HCC or decompensated liver disease requiring transplantation).
Primary outcome measures
- Percentage of anti-HDV positive [Time frame: At diagnosis during the baseline]
Secondary outcome measures (2)
- HDV-positive patients [Time frame: At diagnosis during the baseline]
- HDV positivity data [Time frame: At diagnosis during the baseline]
Eligibility criteria
Inclusion criteria
- Patients aged ≥18 years.
- Hospitalized at the Department of Medicine of ASST Papa Giovanni XXIII in Bergamo, or attending the SerD or the Penitentiary Health Service of Bergamo.
- HBsAg positivity.
- Obtaining informed consent.
Exclusion criteria
- Lack of informed consent
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
- Asst Papa Giovanni Xxiii — Bergamo
Identifiers
NCT: NCT07317011 · HDV Reflex