EUCTR2018-002210-12-NL进行中（未招募）1 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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed and dated ICF prior to any study-mandated procedure;
- •2. Subject completed the 6-month, double-blind treatment period in study ID 069A301;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 97
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •1. Pregnant / planning to become pregnant or lactating subject;
- •2. 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;
- •3. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results as per investigator judgment.
- •In addition, the subject must not be enrolled in study ID-069A302 if at any time during study ID-069A301, one of the following criteria was met:
- •4. Subject’s eGFR per the Chronic Kidney Disease Epidemiology Collaboration creatinine equation < 15 mL/min/1.73 m2;
- •5. Subject experienced an event of acute kidney injury Common Terminology Criteria for Adverse Event (CTCAE) grade 2 or above;
- •6. Subject experienced an event of stroke CTCAE grade 3 or above;
- •7. Subject experienced an event of heart failure leading to in-patient hospitalization or prolongation of ongoing hospitalization.
研究者
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