Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Key facts
- Who runs it
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 266 people, planned
- Started
- 6 May 2024
- Expected to end
- 31 Aug 2028
- Type of study
- Observational
- Treatments tested
- Bulevirtide
- Record updated
- 6 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- Age≥18 years
- HDV-related compensated cirrhosis defined by positivity of HDV RNA for at least 6 months and clinical or laboratory or histological diagnosis of cirrhosis
- Started treatment with BLV monotherapy between September 1st 2019 and 2025
Who cannot take part
- PegIFN alpha therapy
- Chronic hepatitis without any evidence of cirrhosis
- Decompensated cirrhosis
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Retrospective and prospective, pharmacological, multicentre, non-profit observational study.
Read full original descriptionShow less
Consecutive patients with HDV-related compensated cirrhosis starting Bulevirtide 2 mg/day from September 2019 to December 2025 will be enrolled in the study.
Aim of this study is to investigate virological and clinical effectiveness of Bulevirtide 2 mg/day in patients with HDV-related compensated cirrhosis in the real-life setting.
Primary endpoint of the study is the rate of virological response, defined as at least 2 Log decline or undetectable HDV RNA compared to baseline, at week 96 of treatment.
The group in the trial
- Hepatis Delta
Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously
Treatment: Bulevirtide
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis (SAVE-D Study)
- Record updated
- 6 November 2026