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

NCT06397859 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 266

Last updated 2024-06-17

No results posted yet for this study

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.

Conditions

  • Hepatitis D

Interventions

DRUG

Bulevirtide

dose of 2 mg/day subcutaneously

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-06
Primary Completion
2026-06-30
Completion
2026-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06397859 on ClinicalTrials.gov