NCT02239354终止1 期
A Prospective, Multicenter, Open-Label, First-in-Human Phase 1/2 Study With Two Cohorts to Evaluate the Safety, Tolerability, and Efficacy of Various Doses of VC-01™ Combination Product in Subjects With Type 1 Diabetes Mellitus
ViaCyte3 个研究点 分布在 2 个国家目标入组 19 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- Number of Adverse Events Reported During the Study.
研究概览
简要总结
The purpose of this trial is to test if VC-01™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women (non-pregnant and non-childbearing potential)
- •Diagnosis of type 1 diabetes mellitus for at least 3 years
- •Stable diabetic treatment
- •Willingness to use a continuous glucose meter
- •Acceptable candidate for implantation
排除标准
- •Advanced complications associated with diabetes
- •Immunosuppressive therapy
结局指标
主要结局
Number of Adverse Events Reported During the Study.
时间窗: Thru the Month 24 Visit
Change in C-peptide
时间窗: Baseline to the Month 6 Visit
The Full Analysis Set (FAS) is the intent-to-treat (ITT) set of subjects. This set is defined as all T1DM subjects who were enrolled into the study and received implantation of at least one VC-01-250 or sentinel unit on Study Day 1. The FAS (Cohort 2 T1DM subjects who meet the FAS criteria) will be used to analyze the primary efficacy endpoint.
次要结局
未报告次要终点
研究者
研究点 (3)
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