NCT07442760

ePro Diary - HDV ( MACROLIVER )

Recruiting now Last updated 2 March 2026

What this trial tests

trial in HDV in 55 participants. Currently enrolling.

Timeline

31 March 2025

Primary endpoint
31 March 2030

31 March 2030

Quick facts

Lead sponsor	FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	55
Start date	31 March 2025
Primary completion	31 March 2030
Estimated completion	31 March 2030
Sites	1 location across Italy

Conditions studied

• HDV — all drugs for HDV →
• HDV Infection — all drugs for HDV Infection →
• Hepatitis — all drugs for Hepatitis →

Sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS — full company profile →

Who can join

18 and older, any sex, with HDV or HDV Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is part of the MACROLIVER Project, which aims to develop a digital tool for patients and their caregivers to manage liver diseases. Approximately 20-25 million individuals worldwide carry HBsAg and are co-infected with HDV, though geographic variations exist. In Italy, an estimated 10,000-20,000 individuals are affected by Delta hepatitis (HD). These data are approximate, given the absence of current population studies and effective screening methods.

Although considered rare, chronic HD (CHD) is the most aggressive form of viral hepatitis, with most patients progressing rapidly to end-stage liver disease or developing hepatocellular carcinoma at a young age, often requiring liver transplantation. Screening HBsAg-positive patients for Delta co-infection is not widespread, leading to late diagnoses. Additionally, accurate quantification of viral RNA is limited to a few specialized centers.

The lack of effective antiviral therapies has led many Delta hepatitis patients to frequently switch hepatology centers in search of treatments or to miss regular medical check-ups. However, HDV management may change significantly following the recent EMA approval of a new antiviral drug, bulevirtide-an entry inhibitor administered subcutaneously daily-reimbursed in Italy since April 2023. This drug has shown promising results in Phase II and III studies, including in cirrhotic patients with severe portal hypertension.

The COVID-19 pandemic exacerbated this situation, causing reduced access to healthcare facilities and negatively impacting patients with chronic diseases. However, it also accelerated the search for effective, high-quality digital solutions for patient management.

The ePro-Diary HDV proposes to facilitate continuous communication between patients and doctors, monitor key lab values, quality of life questionnaires, and overall health status by an application for mobile phone.

The objectives are twofold: to make patients active participants in their care-enhancing retention and adherence through an "active App-based approach"-and to evaluate changes in patient quality of life with this "active" remote approach. This tool will support clinicians and patients without replacing standard clinical monitoring.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.