Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy: a Multicenter Prospective Real Life Data Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Describe the virological response to BLV in all patients starting BLV therapy for CHD
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients who will start therapy with BLV 2 mg/day from May 2023
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 for CHD
时间窗: Month 12
Percentage of patients with ≥ 2 log IU/ml decline of HDV RNA
次要结局
- Evaluation of the proportion of patients with virological response, defined as a >2 Log decline in HDV-RNA(Month 12)
- Investigation of changes over time in serum levels of AFP (µg/L)(Month 12)
- Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT(Month 12)
- Investigation of changes over time in serum levels of HBsAg (UI/mL)(Month 12)
- Investigation of changes over time in serum levels of platelets (10e9/L)(Month 12)
- Investigation of changes over time in serum levels of albumin (g/dL)(Month 12)
- Evaluation of the proportion of patients with virological response, defined as undetectable HDV-RNA(Month 12)
- Evaluation of the 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(Month 12)
- Evaluation of treatment safety(Month 12)