"Referral Attivo" Delta, Dallo Screening Alla Presa in Carico. (HDV-Reflex)

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis, Delta

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).

• Study Type: Observational
• Enrollment (Estimated): 244

Contacts and Locations

• Study Contact: Name: FRANCESCA FENILI; Email: sperimentazioni@fondazionefrom.it
• Study Contact Backup: Name: Eleonora Sfreddo; Phone Number: +39 0352675134; Email: sperimentazioni@fondazionefrom.it

Study Locations

• Italy
  • Bergamo, Italy
    • Recruiting
    • ASST PAPA GIOVANNI XXIII - Medicine Dept.
    • Contact: Alessandro Loglio; Email: aloglio@asst-pg23.it
    • Principal Investigator: Alessandro Loglio, MD
  • Bergamo, Italy
    • Recruiting
    • ASST Papa Giovanni XXIII - SerD
    • Sub-Investigator: Marco Riglietta, MD
  • Bergamo, Italy
    • Recruiting
    • ASST Papa Giovanni XXIII - SS Sanità Penitenziaria
    • Sub-Investigator: Maria Chiara Pezzoli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients hospitalized (ward or day hospital) at the Department of Medicine of ASST Papa Giovanni XXIII in Bergamo (OMS square and San Giovanni Bianco facility), as well as outpatients attending the SerD and the Penitentiary Health Service of the same ASST, who are indicated for the HBsAg test, will undergo "active HDV referral." Patients who test positive for HBsAg between September 1, 2025, and August 31, 2026, and who provide informed consent, will be included in the study. For all patients, the Microbiology and Virology Laboratory will automatically perform the anti-HDV test and, in case of positivity, automatically perform the HDV RNA test, initiating referral to the Gastroenterology, Hepatology, and Transplantation Unit.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of anti-HDV positive	Estimate the percentage of anti-HDV positive individuals among HBsAg positive hospitalized patients	At diagnosis during the baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HDV-positive patients	Describe the main clinical characteristics of HDV-positive patients included in this study during 2025-2026.	At diagnosis during the baseline
HDV positivity data	Compare the HDV positivity data from 2025-2026 with the data reported in the literature	At diagnosis during the baseline

Collaborators and Investigators

• Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
• Investigators: Study Director: Eleonora Sfreddo, FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepatitis; Hepatitis D
• Other Study ID Numbers: HDV Reflex

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No