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RecruitingNCT06122285D-SHIELDUpdated Nov 5, 2026

Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)

An observational study in Hepatitis D, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational

From the registry’s dates

  • Started May 2023; still recruiting 3 years 6 months later.
Updated Nov 5, 2026Study completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hepatitis D

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03

In context

Hepatitis D

63 studies on the registry are indexed under Hepatitis D; 21 are open to participants now.

This study's planned enrollment of 100 is below the median of 326 across 29 observational studies indexed under Hepatitis D.

Browse Hepatitis D studies →

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 233 studies on the registry; 77 are open to participants now.

Browse Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • HDV-related decompensated cirrhosis (CPT ≥7)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Hepatis Delta

    Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously

    Drug: Bulevirtide

Interventions

06

What researchers measure

Primary outcomes

  1. Describe the virological response to BLV in all patients starting BLV therapy for CHD

    Percentage of patients with undetectable HDV RNA

    Time frame: Month 6

  2. 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

    Time frame: Month 12

Secondary outcomes

  1. 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

    Time frame: Month 6

  2. 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

    Time frame: Month 12

  3. 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

    Time frame: Month 6

  4. 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

    Time frame: Month 12

  5. 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

    Time frame: Month 6

  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

    Time frame: Month 12

  7. Evaluation of the percentage of patients with normal ALT

    Percentage of patients with normal ALT

    Time frame: Month 6

  8. Evaluation of the percentage of patients with normal ALT

    Percentage of patients with normal ALT

    Time frame: Month 12

  9. 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)

    Time frame: Month 6

  10. 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)

    Time frame: Month 12

  11. Investigation of changes over time in serum levels of HBsAg (UI/mL)

    Change in serum levels of HBsAg- by medians and ranges

    Time frame: Month 6

  12. Investigation of changes over time in serum levels of HBsAg (UI/mL)

    Change in serum levels of HBsAg- by medians and ranges

    Time frame: Month 12

  13. Investigation of changes over time in serum levels of albumin (g/dL)

    Change in serum levels albumin- by medians and ranges

    Time frame: Month 6

  14. Investigation of changes over time in serum levels of albumin (g/dL)

    Change in serum levels albumin- by medians and ranges

    Time frame: Month 12

  15. Investigation of changes over time in serum levels of platelets (10e9/L)

    Change in serum levels of platelets - by medians and ranges

    Time frame: Month 6

  16. Investigation of changes over time in serum levels of platelets (10e9/L)

    Change in serum levels of platelets - by medians and ranges

    Time frame: Month 12

  17. Investigation of changes over time in serum levels of AFP (µg/L)

    Change in serum levels of AFP - by medians and ranges

    Time frame: Month 6

  18. Investigation of changes over time in serum levels of AFP (µg/L)

    Change in serum levels of AFP - by medians and ranges

    Time frame: Month 12

  19. Evaluation of treatment safety

    Occurrence of change in serum bile acid levels (µmol/L)

    Time frame: Month 6

  20. Evaluation of treatment safety

    Occurrence of adverse events

    Time frame: Month 6

  21. Evaluation of treatment safety

    Occurrence of change in serum bile acid levels (µmol/L)

    Time frame: Month 12

  22. Evaluation of treatment safety

    Occurrence of adverse events

    Time frame: Month 12

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from May 2023 to primary completion in Nov 2023, 6 months.

Completion moved once since we started tracking on Sep 25, 2026: Dec 2025 → Dec 2027, on Nov 5, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2023
First posted
Nov 8, 2023
StartActual
May 1, 2023
Primary completionActual
Nov 1, 2023
CompletionEst.
Dec 31, 2027was Dec 2025
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Study completion
Dec 31, 2025→Dec 31, 2027
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Study completion Dec 31, 2025→Dec 31, 2027
    + 2 other changes: index terms and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06122285
Lead sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Responsible party
Sponsor
First posted
Nov 8, 2023
Start date
May 1, 2023
Primary completion
Nov 1, 2023
Completion
Dec 31, 2027 (estimated)
Last update
Nov 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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