EUCTR2017-002153-11-GB进行中（未招募）1 期
ong-term Follow-up of ND4 LHON Subjects Treated With GS010 OcularGene Therapy in the RESCUE or REVERSE Phase III Clinical Trials
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
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. Subject was treated with GS010 IVT injection in either of the RESCUE
- •or REVERSE Phase III clinical studies.
- •2. Subject of legal consent age has provided informed consent; subjects
- •that are not of legal consent age have undergone their country-approved clinical trial enrollment consent process.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject is unwilling or unable to comply with the protocol
- •requirements.
- •2. Subject has any medical or psychological condition that, in the opinion of the Investigator, may compromise his or her safe participation in the study.
- •3. Subject is taking or intending to take idebenone during the long-term follow-up study period.
研究者
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