Clinical trial
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis (SAVE-D Study)
Name
IN-IT-589-7118
Description
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.
Trial arms
Trial start
2024-05-06
Estimated PCD
2026-06-30
Trial end
2026-08-31
Status
Not yet recruiting
Treatment
Bulevirtide
dose of 2 mg/day subcutaneously
Arms:
Hepatis Delta
Other names:
Hepcludex
Size
266
Primary endpoint
Investigate the virological response rate to BLV
Week 96
Investigate the virological response rate to BLV
Week 96
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'enrollmentInfo': {'count': 266, 'type': 'ESTIMATED'}}
Updated at
2024-05-03
1 organization
1 product
1 indication
Product
BulevirtideIndication
Hepatitis D