An observational study in Hepatitis, Delta, sponsored by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS · Observational
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.
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).
63 studies on the registry are indexed under Hepatitis D; 21 are open to participants now.
This study's planned enrollment of 244 is below the median of 326 across 29 observational studies indexed under Hepatitis D.
Browse Hepatitis D studies →FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS is the lead sponsor of 20 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Percentage of anti-HDV positive
Estimate the percentage of anti-HDV positive individuals among HBsAg positive hospitalized patients
Time frame: At diagnosis during the baseline
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 baseline
HDV positivity data
Compare the HDV positivity data from 2025-2026 with the data reported in the literature
Time frame: At diagnosis during the baseline
Started Oct 2025 (actual). Primary completion is estimated for Sep 2026, 11 months after the start.
How these figures are worked out, and which studies are left out of them.
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FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS