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 2026-11-06.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational
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.
63 studies on the registry are indexed under Hepatitis D; 21 are open to participants now.
This study's planned enrollment of 266 is below the median of 326 across 29 observational studies indexed under Hepatitis D.
Browse Hepatitis D studies →Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 233 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
Exclusion Criteria:
Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously
Drug: Bulevirtide
dose of 2 mg/day subcutaneously
Also known as: Hepcludex
Investigate the virological response rate to BLV
Percentage of patients with \>2 Log decline in HDV-RNA (IU/mL)
Time frame: Week 96
Investigate the virological response rate to BLV
Percentage of patients with undetectable HDV-RNA (IU/mL)
Time frame: Week 96
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)
Time frame: Week 96
Evaluation of the percentage of patients with normal ALT
Percentage of patients with normal ALT
Time frame: 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
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.
Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) at week 96;
Time frame: 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
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)
Percentage of patients with virological, biochemical and clinical responses from year 2 (week 96) to year 5
Time frame: 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
Time frame: Week 96
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 ↗
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