Asst Papa Giovanni Xxiii
Bergamo, Italy
Location status: Recruiting
NCT Number: NCT07317011
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
Bergamo, Italy
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At diagnosis during the baseline
Estimate the percentage of anti-HDV positive individuals among HBsAg positive hospitalized patients
Time frame: At diagnosis during the baseline
Describe the main clinical characteristics of HDV-positive patients included in this study during 2025-2026.
Time frame: At diagnosis during the baseline
Compare the HDV positivity data from 2025-2026 with the data reported in the literature
Contact information is provided by the study sponsor or research team.
Eleonora Sfreddo
CONTACT
FRANCESCA FENILI
CONTACT
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Other
Acronym: HDV-Reflex
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