NCT02771379已完成不适用
A Non-interventional Study of Clinical Experience in Patients Prescribed Raxone® for the Treatment of Leber's Hereditary Optic Neuropathy (LHON)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 26
- 主要终点
- Long-term safety profile of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care.
研究概览
简要总结
This study is a multicentre, prospective, non-interventional post-authorisation safety study (PASS) of the clinical outcomes for patients with LHON treated with Raxone®.
No medication will be provided as part of this study. Raxone® will be obtained through commercial channels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient prescribed Raxone® for the treatment of LHON;
- •Patient has completed an Informed Consent Form (ICF) indicating that he/she (or a legally acceptable representative) has been informed of all pertinent aspects of the study and has agreed to participate in the study;
- •Patient is not participating in any interventional study.
排除标准
- •No explicit exclusion criteria exist to avoid selection bias and to allow for documentation of routine clinical practice.
研究组 & 干预措施
Patients who are treated with Raxone®
干预措施: Idebenone (Drug)
结局指标
主要结局
Long-term safety profile of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care.
时间窗: up to 5 years
Safety will be assessed by the collection and analysis of adverse events of special interest (AESIs), frequency and nature of AEs and serious adverse events (SAEs), adverse drug reactions (ADRs) and serious adverse drug reactions (SADRs)
次要结局
- Long-term effectiveness of Raxone® in the treatment of patients with LHON when used under conditions of routine clinical care(up to 5 years)
研究者
研究点 (26)
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