Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis (SAVE-D Study)
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
266 participants
May 6, 2024
OBSERVATIONAL
Conditions
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. 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.
Eligibility
Inclusion Criteria3
- 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
Exclusion Criteria3
- Chronic hepatitis without any evidence of cirrhosis
- Decompensated cirrhosis
- PegIFN alpha therapy
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Interventions
dose of 2 mg/day subcutaneously
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06397859