Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) Patients in Italy: a National Real Life Data Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Describe the virological response to BLV in all patients starting BLV therapy
研究概览
简要总结
Spontaneous, pharmacological observational, no-profit, retrospective, multi-center.
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 retrospectively/longitudinally.
The primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy, 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.
All patients with active HDV chronic hepatopathy (quantifiable HDV-RNA) who initiated 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •18 years of age or older
- •Chronic hepatitis delta
- •Compensated cirrhosis HDV related
- •Bulevertide 2 mg/day within December 15, 2020, to December 31, 2022
排除标准
- •HDV-related decompensated cirrhosis (CPT ≥7)
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
Describe the virological response to BLV in all patients starting BLV therapy
时间窗: Month 12
percentage of patients with ≥ 2 log IU/ml decline of HDV RNA at month 12 of BLV therapy, compared to baseline.
次要结局
- Evaluation of treatment safety(Month 12)
- Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT, at the twelfth month of treatment(Month 12)
- Evaluation of the percentage of patients with normal ALT, at the twelfth month of treatment(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, at the end of the first year of treatment(Month 12)