Hepatitis DSAVE-DNCT06397859
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
An observational study of Hepatitis D, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Retrospective and prospective, pharmacological, multicentre, non-profit observational study. Consecutive patients with HDV-related compensated cirrhosis starting Bulevirtide 2 mg/day from September 2019 to December 2025 will be enrolled in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis D
- What is being tested?
- Bulevirtide
- Type of treatment
- Injection or infusion
- How many people
- 266 participants
- Where
- 1 siteItaly
- Study dates
- 6 May 2024to 31 Aug 2028
- 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: The study will enrol patients with chronic HDV infection (defined by HDV RNA positivity for at least 6 months) who started or will start BLV 2 mg/day during the study period at the S.C. Gastroenterology and Hepatology (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) and at participating centers, and who meet the inclusion criteria and do not present any of the exclusion criteria. The decision to treat patients with BLV is determined based on the clinical judgment of the treating physicians prior to study enrolment.
Who may be able to join
- 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 join
- Chronic hepatitis without any evidence of cirrhosis
- Decompensated cirrhosis
- PegIFN alpha therapy
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
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
Milan, 20122
Pietro Lampertico, MD, 0255035432, pietro.lampertico@unimi.it
About this study
Official title: Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis (SAVE-D Study)
Retrospective and prospective, pharmacological, multicentre, non-profit observational study.
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.
- Conditions
- Hepatitis D
- Being tested
- Bulevirtide
- Medical subject headings
- Hepatitis D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BulevirtideDrug
Also called Hepcludex
dose of 2 mg/day subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Hepatis Delta | Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously Receives: Drug: Bulevirtide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the virological response rate to BLV
Percentage of patients with >2 Log decline in HDV-RNA (IU/mL)
Measured: Week 96
Investigate the virological response rate to BLV
Percentage of patients with undetectable HDV-RNA (IU/mL)
Measured: Week 96
Secondary outcomes (7)
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA (IU/mL) or undetectable HDV-RNA (IU/mL) along with normalization of ALT (combined response)
Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT (combined response)
Measured: Week 96
Evaluation of the percentage of patients with normal ALT
Percentage of patients with normal ALT
Measured: Week 96
Evaluation of the percentage of patients with <1 Log decrease in HDV-RNA
Percentage of patients with < 1 log decline HDV RNA levels
Measured: Week 96
Evaluation of the percentage of patients with clinical response, i.e., the percentage of patients who remain free of liver complications, such as HCC or decompensation, at week 96 of treatment.
Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) at week 96;
Measured: Week 96
Evaluation of the correlation between baseline or on-treatment biochemical/clinical variables and virological response
Baseline and on-treatment biochemical and clinical variables predicting virological response to BLV
Measured: Week 96
Evaluation of virological and clinical responses from year 2 (week 96) to year 5 only (only if data of this patients is available)
Percentage of patients with virological, biochemical and clinical responses from year 2 (week 96) to year 5
Measured: Year 5
Evaluation of bile acids levels over time and correlation of bile levels with virological response rates
Correlation between bile acids levels and virological response over time
Measured: Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start6 May 2024
- Primary completion30 Jun 2026
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis DStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397859
- Sponsor's protocol ID
- IN-IT-589-7118
- Acronym
- SAVE-D
- Status last verified
- Nov 2026
- First submitted
- 30 Apr 2024
- Last updated
- 6 Nov 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis (SAVE-D Study)
- ClinicalTrials.gov ID
- NCT06397859
- Acronym / sponsor ID
- SAVE-D / IN-IT-589-7118
- Conditions
- Hepatitis D
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 3 May 2024 (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.
Retrospective and prospective, pharmacological, multicentre, non-profit observational study.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatis Delta | – | Drug: BulevirtideBulevirtide (BLV) at a dose of 2 mg/day subcutaneously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enrol patients with chronic HDV infection (defined by HDV RNA positivity for at least 6 months) who started or will start BLV 2 mg/day during the study period at the S.C. Gastroenterology and Hepatology (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) and at participating centers, and who meet the inclusion criteria and do not present any of the exclusion criteria. The decision to treat patients with BLV is determined based on the clinical judgment of the treating physicians prior to study enrolment.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Chronic hepatitis without any evidence of cirrhosis
- Decompensated cirrhosis
- PegIFN alpha therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BulevirtideAlso: Hepcludexdose of 2 mg/day subcutaneously | Drug | Hepatis Delta |
Primary outcome
Investigate the virological response rate to BLV
Time frame: Week 96
Percentage of patients with >2 Log decline in HDV-RNA (IU/mL)
Investigate the virological response rate to BLV
Time frame: Week 96
Percentage of patients with undetectable HDV-RNA (IU/mL)
7 secondary outcomes
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA (IU/mL) or undetectable HDV-RNA (IU/mL) along with normalization of ALT (combined response)
Time frame: Week 96
Evaluation of the percentage of patients with normal ALT
Time frame: Week 96
Evaluation of the percentage of patients with <1 Log decrease in HDV-RNA
Time frame: Week 96
Evaluation of the percentage of patients with clinical response, i.e., the percentage of patients who remain free of liver complications, such as HCC or decompensation, at week 96 of treatment.
Time frame: Week 96
Evaluation of the correlation between baseline or on-treatment biochemical/clinical variables and virological response
Time frame: Week 96
Evaluation of virological and clinical responses from year 2 (week 96) to year 5 only (only if data of this patients is available)
Time frame: Year 5
Evaluation of bile acids levels over time and correlation of bile levels with virological response rates
Time frame: Week 96
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 6 Nov 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.
Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
Milan, Italy
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 Hepatitis D, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 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 3 inclusion and 3 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 6 Nov 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate the virological response rate to BLV (time frame: Week 96). The study lists 2 primary outcomes in all. 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 6 Nov 2026.