Clinical trial Recruiting at 1 site Observational Ages 18 to 100

Active Delta Referral — screening to care pathway

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

Run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS · NCT07317011 · Data updated 2026-11-12

This project will try an automatic 'HDV-reflex' screening to find how common hepatitis D is among adults with hepatitis B who are hospitalized or served by addiction and prison health services in Bergamo.

Quick facts

Study typeObservational
Ages18 Years to 100 Years
SexAll
Enrollment244 (estimated)
SponsorFROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Academic / other
Locations1 site (Bergamo)
StatusRecruiting
StartedOctober 1, 2025
Main results expectedSeptember 30, 2026
Study endsDecember 31, 2026
Registry record updatedJuly 9, 2026
Trial IDNCT07317011 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) who are HBsAg-positive and hospitalized at ASST Papa Giovanni XXIII's Department of Medicine or attending its SerD or Prison Health Service, and who provide informed consent.

Probably not a fit

People who are HBsAg-negative, those receiving care outside the specified Bergamo sites, or individuals who do not provide informed consent are not expected to benefit from this screening initiative.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Hepatitis Delta is the most severe chronic viral hepatitis and occurs only in people who are HBsAg-positive, but it is often missed because routine automatic screening is not in place. Starting in 2025 the project will implement an 'HDV-reflex' test that automatically checks anti-HDV in HBsAg-positive adults at the Department of Medicine, the SerD, and the Prison Health Service of ASST Papa Giovanni XXIII in Bergamo. The team will estimate anti-HDV prevalence in these settings and compare the results with existing outpatient data. The program also intends to improve referral pathways to hepatology and enable earlier use of new antiviral treatment options.

Why it matters

Potential benefit: If successful, the approach could identify many previously undiagnosed HDV cases earlier, enabling timely treatment and reducing the number of patients presenting with advanced HDV-related liver disease.

How similar studies have gone: Reflex HDV screening strategies have been implemented successfully in other countries and have increased detection of HDV among HBV-positive patients.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Asst Papa Giovanni Xxiii
    Bergamo, Italy
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.