CTIS2022-501146-30-00进行中（未招募）1 期
A Long-Term Follow-up Study to Evaluate the Safety and Efficacy of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Adults with Late-Onset OTC Deficiency
ltragenyx Pharmaceutical Inc.0 个研究点目标入组 11 人开始时间: 2022年10月3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
- 11
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Completed the Week 52 visit in Study 301OTC01. Note that the Day 0 visit of Study 301OTC02 may coincide with the Week 52 visit of Study 301OTC01., Willing and able to provide written informed consent., Willing, able, and committed to comply with scheduled study site visits, study procedures, and requirements.
排除标准
- •Planned or current participation in another interventional clinical study that may confound the efficacy or safety evaluation of DTX301 during the duration of this study, Any clinically significant medical condition that, in the opinion of the investigator, would pose a risk to subject safety or would impede the study.
研究者
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