Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis (SAVE-D Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Investigate the virological response rate to BLV
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Chronic hepatitis without any evidence of cirrhosis
- •Decompensated cirrhosis
- •PegIFN alpha therapy
研究组 & 干预措施
Hepatis Delta
Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously
干预措施: Bulevirtide (Drug)
结局指标
主要结局
Investigate the virological response rate to BLV
时间窗: Week 96
Percentage of patients with undetectable HDV-RNA (IU/mL)
次要结局
- Evaluation of the percentage of patients with <1 Log decrease in HDV-RNA(Week 96)
- Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA (IU/mL) or undetectable HDV-RNA (IU/mL) along with normalization of ALT (combined response)(Week 96)
- Evaluation of the percentage of patients with clinical response, i.e., the percentage of patients who remain free of liver complications, such as HCC or decompensation, at week 96 of treatment.(Week 96)
- Evaluation of the correlation between baseline or on-treatment biochemical/clinical variables and virological response(Week 96)
- Evaluation of the percentage of patients with normal ALT(Week 96)
- Evaluation of virological and clinical responses from year 2 (week 96) to year 5 only (only if data of this patients is available)(Year 5)
- Evaluation of bile acids levels over time and correlation of bile levels with virological response rates(Week 96)