NCT03162926已完成1 期
An Open-Label Study Evaluating the Safety and Tolerability of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus
ViaCyte1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2017年7月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Incidence of all adverse events reported for subjects
研究概览
简要总结
The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for up to four (4) months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and non-pregnant women of non-childbearing potential
- •Diagnosis of T1DM for a minimum of five (5) years
- •Stable diabetic treatment
- •Willingness to use a continuous glucose meter
- •Acceptable candidate for implantation
排除标准
- •History of islet cell, kidney, and/or pancreas transplant.
- •Two (2) or more severe, unexplained hypoglycemic events within six (6) months of enrollment
- •Uncontrolled or untreated thyroid disease or adrenal insufficiency
- •Diabetic complications such as severe kidney disease or renal dysfunction, proliferative retinopathy, diabetic foot ulcers, amputations attributable to diabetes, and/or severe peripheral neuropathy
- •Non-compliance with current anti-diabetic regimen
研究组 & 干预措施
Single-group
Experimental
Up to six (6) VC-02-20 implants
干预措施: VC-02 Combination Product (aka PEC-Direct) (Combination Product)
结局指标
主要结局
Incidence of all adverse events reported for subjects
时间窗: Thru the Month 4 Visit]
次要结局
未报告次要终点
研究者
研究点 (1)
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