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

NCT07317011 | Recruiting

• 1 other identifier: HDV Reflex
• Study Type: observational
• Target: 244
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatitis, Delta

Outcome Measures

Primary Outcomes (1)

• Percentage of anti-HDV positive

  Estimate the percentage of anti-HDV positive individuals among HBsAg positive hospitalized patients

  At diagnosis during the baseline

Secondary Outcomes (2)

• HDV-positive patients

  At diagnosis during the baseline

• HDV positivity data

  At diagnosis during the baseline

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Lack of informed consent

Sponsors & Collaborators

• FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS: lead

Study Sites (3)

ASST PAPA GIOVANNI XXIII - Medicine Dept.

Bergamo, Italy

RECRUITING

ASST Papa Giovanni XXIII - SerD

Bergamo, Italy

RECRUITING

ASST Papa Giovanni XXIII - SS Sanità Penitenziaria

Bergamo, Italy

RECRUITING

MeSH Terms

Conditions

Hepatitis D

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Eleonora Sfreddo

  FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

  STUDY DIRECTOR

Central Study Contacts

Eleonora Sfreddo

CONTACT

+39 0352675134; sperimentazioni@fondazionefrom.it

FRANCESCA FENILI

CONTACT

sperimentazioni@fondazionefrom.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

IT (3)