EUCTR2016-003430-25-GB进行中（未招募）1 期
A Long-Term Follow-up Study to Evaluate the Safety, Tolerability, and Efficacy of Adeno-Associated Virus (AAV) rh10-Mediated Gene Transfer of Human Factor IX in Adults With Moderate/Severe to Severe Hemophilia B
ltragenyx Pharmaceutical, Inc.0 个研究点目标入组 6 人开始时间: 2017年3月13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
- 6
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
入选标准
- •1. Willing and able to provide written informed consent
- •2. Completed the Cohort 1/Week 52 or Cohort 2/week 44 visit in Study 101HEMB01
- •3. Willing to stop prophylactic treatment with recombinant FIX at specified time points during the study if medically acceptable
- •4. Willing, able, and committed to comply with scheduled study site visits, study procedures, and requirements
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Planned or current participation in another interventional clinical study that may confound the safety or efficacy evaluation of DTX101 during the duration of this study
- •2. 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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