Clinical Trial

Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis

Study acronym: SAVE-D
Recruiting
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Record status
This record was last updated June 17, 2024 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-04-30.
Status change: Not Yet Recruiting → Recruiting 2024-06-14
Trial Details
NCT Number NCT06397859
Lead Sponsor Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions Hepatitis D
Enrollment 266 participants
Start Date 2024-05-06
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2024-06-17