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"Referral Attivo" Delta, Dallo Screening Alla Presa in Carico.

"Referral Attivo" Delta, Dallo Screening Alla Presa in Carico.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07317011
Acronym
HDV-Reflex
Enrollment
244
Registered
2026-01-05
Start date
2025-10-01
Completion date
2026-12-31
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis, Delta

Brief summary

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).

Interventions

None listed

Sponsors

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of anti-HDV positiveAt diagnosis during the baselineEstimate the percentage of anti-HDV positive individuals among HBsAg positive hospitalized patients

Secondary

MeasureTime frameDescription
HDV-positive patientsAt diagnosis during the baselineDescribe the main clinical characteristics of HDV-positive patients included in this study during 2025-2026.
HDV positivity dataAt diagnosis during the baselineCompare the HDV positivity data from 2025-2026 with the data reported in the literature

Countries

Italy

Contacts

CONTACTEleonora Sfreddo
sperimentazioni@fondazionefrom.it+39 0352675134
CONTACTFRANCESCA FENILI
sperimentazioni@fondazionefrom.it
STUDY_DIRECTOREleonora Sfreddo

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026