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临床试验/EUCTR2016-002069-77-HU
EUCTR2016-002069-77-HU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

Regulus Therapeutics Inc.0 个研究点目标入组 200 人开始时间: 2016年10月18日最近更新:
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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