长期布勒韦肽单药治疗 HDV 相关代偿性肝硬化患者的疗效和临床结果 (SAVE-D)
长期布勒韦肽单药治疗 HDV 相关代偿性肝硬化患者的有效性和临床结果（SAVE-D 研究）
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.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习地点
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Milan、意大利、20122
- 招聘中
- Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
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接触：
- Pietro Lampertico, MD
- 电话号码：0255035432
- 邮箱：pietro.lampertico@unimi.it
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The study will enrol patients with chronic HDV infection (defined by HDV RNA positivity for at least 6 months) who started or will start BLV 2 mg/day during the study period at the S.C. Gastroenterology and Hepatology (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) and at participating centers, and who meet the inclusion criteria and do not present any of the exclusion criteria. The decision to treat patients with BLV is determined based on the clinical judgment of the treating physicians prior to study enrolment.
描述
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
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：OTHER
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Hepatis Delta
Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously |
dose of 2 mg/day subcutaneously
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Investigate the virological response rate to BLV
大体时间：Week 96
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Percentage of patients with >2 Log decline in HDV-RNA (IU/mL) |
Week 96
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Investigate the virological response rate to BLV
大体时间：Week 96
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Percentage of patients with undetectable HDV-RNA (IU/mL) |
Week 96
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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)
大体时间：Week 96
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Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT (combined response) |
Week 96
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Evaluation of the percentage of patients with normal ALT
大体时间：Week 96
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Percentage of patients with normal ALT |
Week 96
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Evaluation of the percentage of patients with <1 Log decrease in HDV-RNA
大体时间：Week 96
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Percentage of patients with < 1 log decline HDV RNA levels |
Week 96
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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.
大体时间：Week 96
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Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation) at week 96; |
Week 96
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Evaluation of the correlation between baseline or on-treatment biochemical/clinical variables and virological response
大体时间：Week 96
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Baseline and on-treatment biochemical and clinical variables predicting virological response to BLV |
Week 96
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Evaluation of virological and clinical responses from year 2 (week 96) to year 5 only (only if data of this patients is available)
大体时间：Year 5
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Percentage of patients with virological, biochemical and clinical responses from year 2 (week 96) to year 5 |
Year 5
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Evaluation of bile acids levels over time and correlation of bile levels with virological response rates
大体时间：Week 96
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Correlation between bile acids levels and virological response over time |
Week 96
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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