HDVNCT07442760
ePro Diary - HDV ( MACROLIVER )
An observational study of HDV and HDV Infection, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HDV, HDV Infection, Hepatitis
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2025to 31 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age > 18 years
- Diagnosis of Delta infection (anti-HDV positivity)
- Signed informed consent
- Ability to adequately understand instructions for correctly using mobile device applications.
Who cannot join
- Refusal or inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST-Papa Giovanni XXIII
Bergamo, Italy, 24127
Alessandro Loglio, MD, 035 2674259 ext. + 39, gastroenterologia.liver@asstpg23.it
About this study
Official title: 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.
Read more
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.
- Conditions
- HDV, HDV Infection, Hepatitis
- Medical subject headings
- Hepatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every year for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start31 Mar 2025
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HDVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442760
- Sponsor's protocol ID
- ePro Diary - HDV
- Status last verified
- Feb 2026
- First submitted
- 19 May 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Patient is the Main Protagonist of His Care Journey
- ClinicalTrials.gov ID
- NCT07442760
- Acronym / sponsor ID
- ePro Diary - HDV
- Conditions
- HDV, HDV Infection, Hepatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETSUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age > 18 years
- Diagnosis of Delta infection (anti-HDV positivity)
- Signed informed consent
- Ability to adequately understand instructions for correctly using mobile device applications.
Key exclusion criteria (1 listed)
- Refusal or inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Scheduled Follow-Up Visits Attended per Patient
Time frame: Every year for 3 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HDV and HDV Infection, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pietro Giani, BS (035 2675134 ext. + 39, gastroenterologia.liver@asstpg23.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Scheduled Follow-Up Visits Attended per Patient (time frame: Every year for 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.