ePro Diary - HDV ( MACROLIVER )

The Patient is the Main Protagonist of His Care Journey

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis; HDV Infection; HDV

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Pietro Giani, BS; Phone Number: + 39 035 2675134; Email: gastroenterologia.liver@asstpg23.it

Study Locations

• Italy
  • Italy
    • Bergamo, Italy, Italy, 24127
      • Recruiting
      • ASST-Papa Giovanni XXIII
      • Contact: Alessandro Loglio, MD; Phone Number: + 39 035 2674259; Email: gastroenterologia.liver@asstpg23.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic HDV hepatitis attending the Hepatology Clinics of ASST Papa Giovanni XXIII who meet the inclusion criteria will be included. For enrolled patients given access to the app, retrospective data collection will also be performed from the time of Delta's hepatitis diagnosis.

Description

Inclusion Criteria:

• Age > 18 years
• Diagnosis of Delta infection (anti-HDV positivity)
• Signed informed consent
• Ability to adequately understand instructions for correctly using mobile device applications.

Exclusion Criteria:

• Refusal or inability to provide informed consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Scheduled Follow-Up Visits Attended per Patient	For each enrolled HDV patient using the ePro Diary - HDV application, the number of scheduled follow-up visits attended will be recorded yearly. The outcome will be expressed as the proportion of attended visits relative to the number of scheduled visits per patient per year. Data will be collected from the ePro Diary - HDV electronic records.	Every year for 3 years

Collaborators and Investigators

• Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: May 19, 2025
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hepatitis
• Other Study ID Numbers: ePro Diary - HDV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No