EUCTR2016-002069-77-GR进行中(未招募)1 期
An Observational Long-Term Safety and Efficacy Follow-Up Study of Subjects Who Have Previously Received RG-101
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 200
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.Previously received at least one dose of RG-101 in a Regulus sponsored clinical study
- •2.Able and willing to adhere to the study visit schedule and comply with all other protocol requirements
- •3.Capable of and willing to provide written informed consent
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Currently participating in any follow-up period of another RG 101 clinical study.
- •Note: Participation in other investigational studies after the conclusion of the parent RG 101 study and/or concurrently with this observational study is allowed.
研究者
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