NCT06633536进行中（未招募）不适用
Real-life Treatment Outcomes of Ravulizumab in Polish Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH). Prospective and Retrospective, Multicenter, Non-interventional Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 64
- 试验地点
- 11
- 主要终点
- Change in LDH levels from index date (first dose of ravulizumab) at every 6 month
研究概览
简要总结
The PNH-RECORD study, a Polish multicenter observational (non-interventional), open-label, retrospective with prospective follow-up.
详细描述
PNH-RECORD study aims to aims to collect data on the patients' characteristics and clinical outcomes of ravulizumab administered in the scope of routine clinical practice in PNH.
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
- •Adult (aged ≥18) patients with PNH receiving ravulizumab treatment in the frames of NDP in Poland.
- •Patients willing to participate in the study and signed ICF.
排除标准
- •Those who participated in ravulizumab clinical trial in the past, and/or those who participated/plans to participate in clinical trial on/after the date of first ravulizumab infusion through NDP.
- •Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
研究组 & 干预措施
Ravulizumab group
Open-label
干预措施: Ravulizumab (Drug)
结局指标
主要结局
Change in LDH levels from index date (first dose of ravulizumab) at every 6 month
时间窗: up to 36 months
Proportion of patients achieving or remaining at LDH<1.5 ULN at every 6 month
时间窗: up to 36 months
次要结局
- Proportion of transfusion-free patients from index date at every 6 month(up to 36 months)
- Number of blood units used per patient-year(up to 36 months)
- To present clinical characteristics(Baseline)
- To present patients characteristics(Baseline)
研究者
研究点 (11)
Loading locations...
相似试验
进行中（未招募）
不适用
Anifrolumab Real-world Treatment Outcomes in Systemic Lupus ErythematosusLupus Erythematosus, SystemicNCT06673043AstraZeneca105
招募中
不适用
Study of the Clinical and Radiological Impact of Ravulizumab in People With Neuromyelitis Optica Spectrum DisorderNeuromyelitis OpticaNCT06398158University of Texas Southwestern Medical Center35
已完成
不适用
Patient-Reported Outcomes of Benralizumab in Real-World Use in Severe Eosinophilic Asthma Patients in Taiwan (BEAT)AsthmaNCT05734339AstraZeneca43
已完成
不适用
Patient Reported Outcomes in Adults With Severe Eosinophilic Asthma on Benralizumab.Severe Eosinophilic AsthmaNCT03833141AstraZeneca170
进行中（未招募）
1 期
Phase 4, Single-Arm Study of Ravulizumab in Adult Participants with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with High-Dose EculizumabEUCTR2019-003440-74-GBAlexion Pharmaceuticals Inc.20