NCT07317011

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 244 (estimated)
• Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hepatitis, Delta

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-08-31
• Completion: 2026-12-31
• First posted: 2026-01-05
• Last updated: 2026-01-05

Locations

3 sites across 1 country: Italy