NCT06397859

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 266 (estimated)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Bulevirtide	dose of 2 mg/day subcutaneously

Timeline

• Start date: 2024-05-06
• Primary completion: 2026-06-30
• Completion: 2026-08-31
• First posted: 2024-05-03
• Last updated: 2024-06-17

Locations

1 site across 1 country: Italy