EUCTR2017-001366-14-IT进行中（未招募）1 期
A long-term safety and efficacy follow-on study in participants with transfusion dependent ß-thalassemia who have previously received GSK2696277 (autologous hematopoietic stem cells genetically modified with GLOBE lentiviral vector encoding for the human beta-globin gene) and completed the TIGET-BTHAL study. - GSK2696277, P2b, beta-thalassemia patient safety follow-on to TIGET BTHAL study
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT0 个研究点目标入组 10 人开始时间: 2020年2月4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
- 10
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
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •1.Participants who have completed study TIGET-BTHAL i.e. who have received treatment and been followed for two years post treatment with GSK2696277.
- •2.For adults; capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. For children; informed assent and/or consent in writing signed by the subject and/or parent(s) / legal representative (according to local regulations and age of the subject).
- •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 3
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- 未提供
研究者
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