EUCTR2018-000425-31-Outside-EU/EEA进行中（未招募）1 期
ong-term Follow-up Study of Participants Following an Open-label, Multi-center, Phase I/II Dose Escalation Trial of a Recombinant Adeno-associated Virus Vector (AAV5-hRKp.RPGR) for Gene Therapy of Adults and Children with X-linked Retinitis Pigmentosa Owing to Defects in Retinitis Pigmentosa GTPase Regulator (RPGR) - Long term follow-up gene therapy study for X-linked Retinitis Pigmentosa
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •Inclusion in the study will be limited to individuals who meet the following criteria:
- •Are able to give informed consent or assent, with or without the guidance of their parent/guardian where appropriate
- •Received AAV5-hRKp.RPGR by sub retinal administration in the prior open-label, Phase I/II, dose escalation study (EudraCT 2016-003967-21)
- •Are willing to adhere to the protocol and long-term follow-up
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 41
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Individuals will be excluded if they are unwilling or unable to meet with the requirements of the study.
研究者
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