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布勒韦肽 (BLV) 治疗意大利慢性丁型肝炎 (CHD) 患者的有效性和安全性 (D-SHIELD) (D-SHIELD)

2026年11月4日 更新者：Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

布勒韦肽 (BLV) 治疗意大利慢性丁型肝炎 (CHD) 患者的有效性和安全性：一项多中心前瞻性现实数据研究

Multicenter pharmacological observational prospective, no-profit, study.

This study was designed to get a "real-life" snapshot across several Italian Hepatology centers. All HDV patients are followed up according to EASL 2017 guidelines. This allows uniformity on the indication for antiviral treatment and management of that antiviral therapy. No off-label medications are used. All data are retrievable from the patient's medical record. In addition, clinical and biochemical data from patients at month 0, 1, 2, 4, 6 and 12 of treatment, and otherwise within the study period, will be collected longitudinally.

The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy for CHD, defined as a >2 Log decline in HDV-RNA or undetectable HDV-RNA (using the Robogene 2.0 quantitative kit, LLQ <6 IU/ml) at month 12 of therapy.

HDV patients who will start therapy with BLV 2 mg/day from May 2023, according to AIFA guidelines, will be consecutively enrolled.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 意大利
    • MI
      • Milan、MI、意大利、20122
        • 招聘中
        • Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All patients with CHD (quantifiable HDV-RNA) who will start treatment with 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 met the inclusion criteria and none of the exclusion criteria.

描述

Inclusion Criteria:

  • 18 years of age or older
  • Chronic hepatitis delta
  • Compensated cirrhosis HDV related
  • Patients who will start therapy with BLV 2 mg/day from May 2023

Exclusion Criteria:

  • HDV-related decompensated cirrhosis (CPT ≥7)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

队列和干预

团体/队列
干预/治疗
Hepatis Delta

Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously
药品：Bulevirtide

dose of 2 mg/day subcutaneously

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
Describe the virological response to BLV in all patients starting BLV therapy for CHD
大体时间：Month 6

Percentage of patients with undetectable HDV RNA
Month 6
Describe the virological response to BLV in all patients starting BLV therapy for CHD
大体时间：Month 12

Percentage of patients with ≥ 2 log IU/ml decline of HDV RNA
Month 12

次要结果测量

结果测量
措施说明
大体时间
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
大体时间：Month 6

Proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
Month 6
Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
大体时间：Month 12

Proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA
Month 12
Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA
大体时间：Month 6

Proportion of patients with virological response, defined as undetectable HDV-RNA
Month 6
Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA
大体时间：Month 12

Proportion of patients with virological response, defined as undetectable HDV-RNA
Month 12
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
大体时间：Month 6

Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
Month 6
Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
大体时间：Month 12

Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
Month 12
Evaluation of the percentage of patients with normal ALT
大体时间：Month 6

Percentage of patients with normal ALT
Month 6
Evaluation of the percentage of patients with normal ALT
大体时间：Month 12

Percentage of patients with normal ALT
Month 12
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
大体时间：Month 6

Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation)
Month 6
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
大体时间：Month 12

Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation)
Month 12
Investigation of changes over time in serum levels of HBsAg (UI/mL)
大体时间：Month 6

Change in serum levels of HBsAg- by medians and ranges
Month 6
Investigation of changes over time in serum levels of HBsAg (UI/mL)
大体时间：Month 12

Change in serum levels of HBsAg- by medians and ranges
Month 12
Investigation of changes over time in serum levels of albumin (g/dL)
大体时间：Month 6

Change in serum levels albumin- by medians and ranges
Month 6
Investigation of changes over time in serum levels of albumin (g/dL)
大体时间：Month 12

Change in serum levels albumin- by medians and ranges
Month 12
Investigation of changes over time in serum levels of platelets (10e9/L)
大体时间：Month 6

Change in serum levels of platelets - by medians and ranges
Month 6
Investigation of changes over time in serum levels of platelets (10e9/L)
大体时间：Month 12

Change in serum levels of platelets - by medians and ranges
Month 12
Investigation of changes over time in serum levels of AFP (µg/L)
大体时间：Month 6

Change in serum levels of AFP - by medians and ranges
Month 6
Investigation of changes over time in serum levels of AFP (µg/L)
大体时间：Month 12

Change in serum levels of AFP - by medians and ranges
Month 12
Evaluation of treatment safety
大体时间：Month 6

Occurrence of change in serum bile acid levels (µmol/L)
Month 6
Evaluation of treatment safety
大体时间：Month 6

Occurrence of adverse events
Month 6
Evaluation of treatment safety
大体时间：Month 12

Occurrence of change in serum bile acid levels (µmol/L)
Month 12
Evaluation of treatment safety
大体时间：Month 12

Occurrence of adverse events
Month 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年5月1日

初级完成 (实际的)

2023年11月1日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2023年10月30日

首先提交符合 QC 标准的

2023年11月7日

首次发布 (实际的)

2023年11月8日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 184853

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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