Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment55 (estimated)
SponsorFROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Academic / other
Locations1 site (Bergamo, Italy)
StatusRecruiting
StartedMarch 31, 2025
Main results expectedMarch 31, 2030
Study endsMarch 31, 2030
Registry record updatedMarch 2, 2026
Trial IDNCT07442760 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.