ePro Diary for people with HDV (MACROLIVER)
Official title: The Patient is the Main Protagonist of His Care Journey
Run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS · NCT07442760 · Data updated 2026-11-12
This project will try a mobile ePro diary app to help adults with Delta hepatitis (HDV) track symptoms and share health information with their care team.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 55 (estimated) |
| Sponsor | FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS Academic / other |
| Locations | 1 site (Bergamo, Italy) |
| Status | Recruiting |
| Started | March 31, 2025 |
| Main results expected | March 31, 2030 |
| Study ends | March 31, 2030 |
| Registry record updated | March 2, 2026 |
| Trial ID | NCT07442760 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (over 18) with confirmed Delta infection (anti-HDV positive) who can use a smartphone or tablet and provide informed consent.
✕Probably not a fit
People who are not HDV-positive, who cannot or will not use mobile device apps, or who cannot give informed consent are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project within the MACROLIVER initiative aims to develop a digital tool (an electronic patient-reported outcomes diary) for patients with HDV and their caregivers. Adults with confirmed anti-HDV positivity will be asked to use a mobile application to record symptoms, medications, and other relevant health data with informed consent. The study collects real-world patient-reported information to characterize symptom patterns, disease impact, and app usability in routine care. Data are collected at ASST-Papa Giovanni XXIII in Bergamo, Italy, and will inform further tool development and wider implementation strategies.
Why it matters
Potential benefit: If successful, the ePro diary could help patients and clinicians detect symptom changes earlier and improve day-to-day disease management.
How similar studies have gone: Electronic symptom diaries and ePRO tools have improved symptom monitoring in other chronic liver diseases and viral hepatitis, but dedicated ePRO work for HDV is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
ASST-Papa Giovanni XXIII
Bergamo, Italy, Italy Recruiting
Study contacts
- Study coordinator: Pietro Giani, BS
- Email: gastroenterologia.liver@asstpg23.it
- Phone: 035 2675134
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Understanding Hepatitis D and its impact on patients
This study is trying to understand how Hepatitis D affects patients by looking at their backgrounds and health to help create better treatment plans.
-
Larsucosterol for people with severe alcohol-associated hepatitis
This trial will test whether larsucosterol helps people with severe alcohol-associated hepatitis survive 90 days without needing a liver transplant.
-
Untreated or Unknown HBV, HDV, and HCV in South-East Austria: See if People Need Care
This study looks at past test results to see how many people in South-East Austria have hepatitis B, hepatitis D coinfection, or hepatitis C that hasn’t been treated yet or isn’t known, and then invites them for care.
-
Investigating symptoms and blood test characteristics of acute hepatitis in children
This study is trying to learn more about the symptoms and blood test results of children with acute hepatitis to help doctors recognize and manage the condition better.
-
Comparing two types of ultrasound for patients with viral hepatitis
This study is testing whether a new ultraportable ultrasound is better than the regular ultrasound for helping patients with viral hepatitis get accurate diagnoses and feel more comfortable during the process.
-
Low dead-space syringe and needle distribution for people who inject drugs in low- and middle-income countries
This program will test whether offering low dead-space syringes and needles to people who inject drugs at needle and syringe programs in several low- and middle-income countries increases acceptability and use of safer injecting equipment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.