EUCTR2017-003104-42-NL进行中（未招募）1 期
A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Retinal Gene Therapy in Subjects with Choroideremia Previously Treated with Adeno-Associated Viral Vector Encoding Rab Escort Protein-1 (AAV2-REP1) in an Antecedent Study
ightstaRx Ltd0 个研究点目标入组 167 人开始时间: 2021年4月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 167
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
- Male
入选标准
- •Are willing and able to give informed consent for participation in the study, and
- •Have received a sub-retinal injection of AAV2-REP1 for CHM and have exited an antecedent study
- •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 167
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects are not eligible for study participation if they meet the following exclusion criterion.
- •a. In the opinion of the investigator and/or the Sponsor, it is not in the subject’s best interest to participate in the study.
研究者
相似试验
进行中（未招募）
1 期
A long-term follow-up study to evaluate the safety and efficacy of retinal gene therapy in subjects with Choroideremia previously treated with AAV2-REP1 and in subjects with X-Linked Retinitis Pigmentosa previously treated with AAV8-RPGR in an antecedent studyEUCTR2017-003104-42-DEightstaRx Ltd (A Biogen Company)330
进行中（未招募）
1 期
A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RGX-501EUCTR2019-004496-39-NLREGENXBIO Inc.12
进行中（未招募）
1 期
A long-term follow-up study to evaluate the safety and efficacy of retinal gene therapy in subjects with Choroideremia previously treated with AAV2- REP1 in an antecedent study and in subjects with X-Linked Retinitis Pigmentosa previously treated with AAV8-RPGR in an antecedent studyChoroideremia (CHM)X-Linked Retinitis Pigmentosa (XLRP)MedDRA version: 20.1Level: LLTClassification code 10008791Term: ChoroideremiaSystem Organ Class: 100000004853MedDRA version: 20.0Level: PTClassification code 10038914Term: Retinitis pigmentosaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2017-003104-42-DKightstaRx Ltd (A Biogen Company)330
尚未招募
3 期
A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Retinal Gene Therapy in Subjects with Choroideremia Previously Treated with Adeno-Associated Viral Vector Encoding Rab Escort Protein-1 (AAV2-REP1)
and in Subjects with X-Linked Retinitis Pigmentosa Previously Treated with Adeno-Associated Viral Vector Encoding RPGR (AAV8-RPGR) in an Antecedent Study2023-507994-16-00Biogen Idec Research Limited54
已完成
2 期
A Long-term Follow-up Study to Evaluate the Safety and Efficacy of RGX-501familial hypercholesterolaemia10013317NL-OMON49424REGENXBIO Inc2