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Recruiting

NCT Number: NCT07317011

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

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.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asst Papa Giovanni Xxiii

Bergamo, Italy

Location status: Recruiting

Location contact

Alessandro Loglio

CONTACT

[email protected]

Alessandro Loglio, MD

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of anti-HDV positive

    Time frame: At diagnosis during the baseline

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

Secondary outcomes

  1. HDV-positive patients

    Time frame: At diagnosis during the baseline

    Describe the main clinical characteristics of HDV-positive patients included in this study during 2025-2026.

  2. HDV positivity data

    Time frame: At diagnosis during the baseline

    Compare the HDV positivity data from 2025-2026 with the data reported in the literature

Study contacts

Contact information is provided by the study sponsor or research team.

Eleonora Sfreddo

CONTACT

[email protected]

+39 0352675134

FRANCESCA FENILI

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Other

Registry information

Acronym: HDV-Reflex

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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