NCT07116044已完成不适用
Assessment of Response and Impact on Safety, Adherece Anc Persistent During Treatment in an Observational Trial for the Evaluation of the Long-term Effectiveness of Bulevirtide in Patients With Chronic Delta Hepatitis: the ARISTOTELE Study
University of Molise1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年6月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Efficacy of bulevirtide
研究概览
简要总结
- The study is non-interventional, multicenter, non-profit
- The primary objective of the study is to evaluate the safety and efficacy in clinical practice of the drug Bulevirtide in the treatment of patients with chronic HDV hepatitis. The drug is already approved and indicated in the treatment of patients with the aforementioned infectious pathology.
- The Coordinating Center and the Principal Investigator of the study in question will be, respectively, the Department of Medical Health Sciences "V. Tiberio" and the undersigned Prof. Luca Rinaldi in cooperation with the Azienda dei Colli, Cotugno Hospital in Naples, Dr Antonio Izzi.
- As regards the further economic aspects, it is underlined that no compensation of any kind is foreseen for the subjects participating in the study and that there are no expenses borne by the subjects participating in the study. The study will be coordinated, managed and analyzed independently.
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
- •Patients with HDV and HBV-related liver disease considered suitable for antiviral or immunomodulatory treatment.
- •Absence of contraindications to the use of Bulevirtide
- •Age over 18 years.
- •Patients born to therapy or already undergoing cycles of therapy with standard interferon or pegylated.
- •Informed consent to study participation
排除标准
- •Specific contraindications to bulevirtide • Presence of decompensated liver disease or other conditions that may interfere with study participation or interpretation of results
结局指标
主要结局
Efficacy of bulevirtide
时间窗: 12 months
Evaluate the virological response to treatment with bulevirtide, measured as reduction or clearance of serum or plasma HDV-RNA, after 12 months of treatment.
次要结局
- Maintenance and Adherence to Therapy(12 months)
研究者
Luca Rinaldi
Associate Professor
University of Molise
研究点 (1)
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