Retrospective Analysis of the Efficiency of Caplacizumab in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura (aTTP)- REACT-2020
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Treatment of aTTP with caplacizumab
研究概览
简要总结
The objective of this national, prospective, multi-centre observational study is to describe the prescription rational and practice in Germany, confirm the efficacy of caplacizumab in a real-world setting, and identify predicting factors in iTTP-patients with regard to persistent autoimmune activity, therapy guidance and risk of complications. The rational is to develop new treatment algorithms that optimize overall patient outcome and reduce treatment cost.
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
- •Confirmed diagnosis of an acute episode of acquired thrombotic thrombocytopenic purpura
- •Treatment with at least one single dose of caplacizumab (10 mg i.v. or s.c.)
- •Male or female patients ≥ 18 years of age
- •signed written informed consent
排除标准
- •Hereditary thrombotic thrombocytopenic purpura
- •disability to give informed consent
研究组 & 干预措施
Registergroup
Patients with acquired Thrombotic Thrombocytopenic Purpura, who have been treated with caplacizumab (Cablivi®)
干预措施: Cablivi® (Drug)
结局指标
主要结局
Treatment of aTTP with caplacizumab
时间窗: Enrollment
Description of the prescription rationale and practice of caplacizumab in the treatment of aTTP
次要结局
- Stabilization of thrombocyte(Enrollment)
- Normalization of haptoglobin(Enrollment)
- Effect of caplacizumab on adjunct treatments with PEX(Enrollment)
- Normalization of LDH(Enrollment)
- Risk factors for adverse outcomes(Enrollment)
- Risk factors for complications(Enrollment)
- Risk factors for persistent autoimmune activity(Enrollment)
- Parameters for therapy guidance(Enrollment)
- Effect of caplacizumab on adjunct treatments(Enrollment)
研究者
Prof. Dr. Paul Brinkkoetter
Prof. MD, Consultant in Nephrology
University of Cologne