Hepatitis DD-SHIELDNCT06122285
Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)
An observational study of Hepatitis D, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Multicenter pharmacological observational prospective, no-profit, study. This study was designed to get a "real-life" snapshot across several Italian Hepatology centers. All HDV patients are followed up according to EASL 2017 guidelines. 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
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2023to 31 Dec 2027
- 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: All patients with CHD (quantifiable HDV-RNA) who will start treatment with 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 met the inclusion criteria and none of the exclusion criteria.
Who may be able to join
- 18 years of age or older
- Chronic hepatitis delta
- Compensated cirrhosis HDV related
- Patients who will start therapy with BLV 2 mg/day from May 2023
Who cannot join
- HDV-related decompensated cirrhosis (CPT ≥7)
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, MI, 20122
Pietro Lampertico, MD, 0255035432, pietro.lampertico@unimi.it
About this study
Official title: Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy: a Multicenter Prospective Real Life Data Study
Multicenter pharmacological observational prospective, no-profit, study.
This study was designed to get a "real-life" snapshot across several Italian Hepatology centers. All HDV patients are followed up according to EASL 2017 guidelines. This allows uniformity on the indication for antiviral treatment and management of that antiviral therapy. No off-label medications are used. All data are retrievable from the patient's medical record. In addition, clinical and biochemical data from patients at month 0, 1, 2, 4, 6 and 12 of treatment, and otherwise within the study period, will be collected longitudinally.
Read more
The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy for CHD, defined as a >2 Log decline in HDV-RNA or undetectable HDV-RNA (using the Robogene 2.0 quantitative kit, LLQ <6 IU/ml) at month 12 of therapy.
HDV patients who will start therapy with BLV 2 mg/day from May 2023, according to AIFA guidelines, will be consecutively enrolled.
- 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
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.
Describe the virological response to BLV in all patients starting BLV therapy for CHD
Percentage of patients with undetectable HDV RNA
Measured: Month 6
Describe the virological response to BLV in all patients starting BLV therapy for CHD
Percentage of patients with ≥ 2 log IU/ml decline of HDV RNA
Measured: Month 12
Secondary outcomes (22)
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
Proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
Measured: Month 6
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
Proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
Measured: Month 12
Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA
Proportion of patients with virological response, defined as undetectable HDV-RNA
Measured: Month 6
Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA
Proportion of patients with virological response, defined as undetectable HDV-RNA
Measured: Month 12
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
Measured: Month 6
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
Measured: Month 12
Evaluation of the percentage of patients with normal ALT
Percentage of patients with normal ALT
Measured: Month 6
Evaluation of the percentage of patients with normal ALT
Percentage of patients with normal ALT
Measured: Month 12
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
Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation)
Measured: Month 6
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
Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation)
Measured: Month 12
Investigation of changes over time in serum levels of HBsAg (UI/mL)
Change in serum levels of HBsAg- by medians and ranges
Measured: Month 6
Investigation of changes over time in serum levels of HBsAg (UI/mL)
Change in serum levels of HBsAg- by medians and ranges
Measured: Month 12
Investigation of changes over time in serum levels of albumin (g/dL)
Change in serum levels albumin- by medians and ranges
Measured: Month 6
Investigation of changes over time in serum levels of albumin (g/dL)
Change in serum levels albumin- by medians and ranges
Measured: Month 12
Investigation of changes over time in serum levels of platelets (10e9/L)
Change in serum levels of platelets - by medians and ranges
Measured: Month 6
Investigation of changes over time in serum levels of platelets (10e9/L)
Change in serum levels of platelets - by medians and ranges
Measured: Month 12
Investigation of changes over time in serum levels of AFP (µg/L)
Change in serum levels of AFP - by medians and ranges
Measured: Month 6
Investigation of changes over time in serum levels of AFP (µg/L)
Change in serum levels of AFP - by medians and ranges
Measured: Month 12
Evaluation of treatment safety
Occurrence of change in serum bile acid levels (µmol/L)
Measured: Month 6
Evaluation of treatment safety
Occurrence of adverse events
Measured: Month 6
Evaluation of treatment safety
Occurrence of change in serum bile acid levels (µmol/L)
Measured: Month 12
Evaluation of treatment safety
Occurrence of adverse events
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 May 2023
- Primary completion1 Nov 2023
- Study completion31 Dec 2027 (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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122285
- Sponsor's protocol ID
- 184853
- Acronym
- D-SHIELD
- Status last verified
- Nov 2026
- First submitted
- 30 Oct 2023
- Last updated
- 5 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy: a Multicenter Prospective Real Life Data Study
- ClinicalTrials.gov ID
- NCT06122285
- Acronym / sponsor ID
- D-SHIELD / 184853
- Conditions
- Hepatitis D
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Nov 2023 (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.
Multicenter pharmacological observational prospective, no-profit, study.
This study was designed to get a "real-life" snapshot across several Italian Hepatology centers. All HDV patients are followed up according to EASL 2017 guidelines. This allows uniformity on the indication for antiviral treatment and management of that antiviral therapy. No off-label medications are used. All data are retrievable from the patient's medical record. In addition, clinical and biochemical data from patients at month 0, 1, 2, 4, 6 and 12 of treatment, and otherwise within the study period, will be collected longitudinally.
The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy for CHD, defined as a >2 Log decline in HDV-RNA or undetectable HDV-RNA (using the Robogene 2.0 quantitative kit, LLQ <6 IU/ml) at month 12 of therapy.
HDV patients who will start therapy with BLV 2 mg/day from May 2023, according to AIFA guidelines, will be consecutively enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- 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
- All patients with CHD (quantifiable HDV-RNA) who will start treatment with 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 met the inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (4 listed)
- 18 years of age or older
- Chronic hepatitis delta
- Compensated cirrhosis HDV related
- Patients who will start therapy with BLV 2 mg/day from May 2023
Key exclusion criteria (1 listed)
- HDV-related decompensated cirrhosis (CPT ≥7)
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 |
|---|---|---|
| Bulevirtidedose of 2 mg/day subcutaneously | Drug | Hepatis Delta |
Primary outcome
Describe the virological response to BLV in all patients starting BLV therapy for CHD
Time frame: Month 6
Percentage of patients with undetectable HDV RNA
Describe the virological response to BLV in all patients starting BLV therapy for CHD
Time frame: Month 12
Percentage of patients with ≥ 2 log IU/ml decline of HDV RNA
22 secondary outcomes
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
Time frame: Month 6
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
Time frame: Month 12
Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA
Time frame: Month 6
Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA
Time frame: Month 12
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
Time frame: Month 6
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
Time frame: Month 12
Evaluation of the percentage of patients with normal ALT
Time frame: Month 6
Evaluation of the percentage of patients with normal ALT
Time frame: Month 12
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
Time frame: Month 6
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
Time frame: Month 12
Investigation of changes over time in serum levels of HBsAg (UI/mL)
Time frame: Month 6
Investigation of changes over time in serum levels of HBsAg (UI/mL)
Time frame: Month 12
Investigation of changes over time in serum levels of albumin (g/dL)
Time frame: Month 6
Investigation of changes over time in serum levels of albumin (g/dL)
Time frame: Month 12
Investigation of changes over time in serum levels of platelets (10e9/L)
Time frame: Month 6
Investigation of changes over time in serum levels of platelets (10e9/L)
Time frame: Month 12
Investigation of changes over time in serum levels of AFP (µg/L)
Time frame: Month 6
Investigation of changes over time in serum levels of AFP (µg/L)
Time frame: Month 12
Evaluation of treatment safety
Time frame: Month 6
Evaluation of treatment safety
Time frame: Month 6
Evaluation of treatment safety
Time frame: Month 12
Evaluation of treatment safety
Time frame: Month 12
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 5 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 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 5 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?
Describe the virological response to BLV in all patients starting BLV therapy for CHD (time frame: Month 6). 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 5 Nov 2026.