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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatis Delta | Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bulevirtide | Drug | dose of 2 mg/day subcutaneously |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the virological response rate to BLV | Percentage of patients with >2 Log decline in HDV-RNA (IU/mL) | Week 96 |
| Investigate the virological response rate to BLV | Percentage of patients with undetectable HDV-RNA (IU/mL) | Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Week 96 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. | Recruiting | Milan | 20122 | Italy |
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| ID | Term |
|---|---|
| D003699 | Hepatitis D |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000718249 | bulevirtide |
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| Evaluation of the percentage of patients with normal ALT |
Percentage of patients with normal ALT |
| 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 | 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; | 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 | 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 | 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 | Week 96 |
| D006505 |
| Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |