2024-513884-20-00招募中3 期
A multi-center, open-label, uncontrolled, single-arm, extension study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 15
- 主要终点
- Treatment-emergent AEs and SAEs
研究概览
简要总结
To determine the long-term safety and tolerability of lucerastat in subjects with Fabry disease
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Post-treatment safety follow-up (FU) period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Signed and dated ICF prior to any study-mandated procedure;
- •Subject completed the 6-month, double-blind treatment period in study ID 069A301;
排除标准
- •Pregnant / planning to become pregnant or lactating subject;
- •Subject considered to be at high risk of developing clinical signs of organ involvement within the time period of the study, as per investigator judgment;
- •Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results as per investigator judgment.
- •If at any time during study ID-069A301, the following criteria was met: Subject’s eGFR per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation < 15 mL/min/1.73 m
- •If at any time during study ID-069A301, the following criteria was met: Subject experienced an event of acute kidney injury Common Terminology Criteria for Adverse Event (CTCAE) grade 2 or above;
- •If at any time during study ID-069A301, the following criteria was met: Subject experienced an event of stroke CTCAE grade 3 or above;
- •If at any time during study ID-069A301, the following criteria was met: Subject experienced an event of heart failure leading to in-patient hospitalization or prolongation of ongoing hospitalization.
结局指标
主要结局
Treatment-emergent AEs and SAEs
Treatment-emergent AEs and SAEs
次要结局
未报告次要终点
研究者
Idorsia Clinical Trial Information
Scientific
Idorsia Pharmaceuticals Ltd.
研究点 (15)
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