NCT07156149进行中（未招募）不适用
Fabhalta Capsules Specified Drug-use Survey(C3 Glomerulopathy, CLNP023B11401)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 33
- 试验地点
- 29
- 主要终点
- Number of patients with infections
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of Fabhalta in patients with C3 glomerulopathy in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 0 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who have used Fabhalta for C3 glomerulopathy (including patients with recurrent C3 glomerulopathy post renal transplant).
排除标准
- •Use of iptacopan for an indication not yet approved under the Clinical Trials Act or GCP (e.g., patient-requested medical treatment, investigator-initiated clinical trial)
研究组 & 干预措施
iptacopan
patients administered iptacopan in clinical practice
结局指标
主要结局
Number of patients with infections
时间窗: 360 Days
Number of patients with infections and type of infections (meningococcal infection, pneumococcal infection, Haemophilus influenzae infection, and other infections based on the causative bacteria) as adverse events/adverse reactions during the treatment period
次要结局
- Incidence of adverse events and adverse reactions(360 Days)
- Changes in UPCR(Baseline, 360 Days)
- Changes in eGFR(Baseline, 360 Days)
- Changes in serum creatinine(360 Days)
- Changes in blood urea nitrogen (BUN)(360 Days)
- Proportion of patients achieving the composite renal endpoint at the final assessment.(360 Days)
- Changes in serum albumin(360 Days)
研究者
研究点 (29)
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