"Referral Attivo" Delta, Dallo Screening Alla Presa in Carico.
ConditionHepatitis, Delta
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorFROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Lack of informed consent
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Percentage of anti-HDV positive
Estimate the percentage of anti-HDV positive individuals among HBsAg positive hospitalized patients
Time frame
At diagnosis during the baselineSecondary outcomes
1
HDV-positive patients
Describe the main clinical characteristics of HDV-positive patients included in this study during 2025-2026.
Time frame
At diagnosis during the baseline2
HDV positivity data
Compare the HDV positivity data from 2025-2026 with the data reported in the literature
Time frame
At diagnosis during the baselineSponsors and contacts
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Source ClinicalTrials.gov