Condition: Hepatitis D · Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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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| Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. | Milan, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06397859