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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

244 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

DELTA DESCRIBE: the French Collaborative Project

NCT05936073

Hepatitis D

RECRUITING

Burden of Hepatitis D Virus (HDV) Infection in Italy

NCT05723068

Chronic Hepatitis D

COMPLETED

HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection

NCT06264583

Hepatitis D

RECRUITING

Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in Patients With HIV-1

NCT06728917

HBV (Hepatitis B Virus) HIV Infection

NOT_YET_RECRUITING

Evaluation of Hepatitis C Viral Load Quantification on DBS in Vietnam

NCT03670251

Hepatitis C Dried Blood Spot

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis, Delta

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.