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

RECRUITINGSponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Actively Recruiting
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Started2024-05-06
Est. completion2026-06-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06397859

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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* Chronic hepatitis without any evidence of cirrhosis
* Decompensated cirrhosis
* PegIFN alpha therapy

Conditions2

Hepatitis DLiver Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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