NCT00627146已完成2 期
Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients
AZ-VUB5 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2000年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- The difference in change in daily insulin need between baseline and month 48, between placebo and ChAgly CD3 treated patients
研究概览
简要总结
Compared to placebo, treatment with ChAgly CD3 has a beneficial effect on preservation of beta cell function and metabolic outcome in type 1 diabetic patients with recent clinical onset of disease that persists until 48 months after administration.
The investigators also hypothesize that in type 1 diabetic patients with recent clinical onset of disease compared to placebo, ChAgly CD3 will be safe and well tolerated between 18 and 48 months after administration, based on assessment of clinical and laboratory adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Type 1 diabetes mellitus included in the phase II therapeutic trial with a humanized non-mitogenic CD3 monoclonal antibody (ChAgly CD3) at time of clinical diagnosis and who agree and are likely to comply with the investigator's instructions
排除标准
- •Any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the patient
- •Use of illicit drugs or over consumption of alcohol (> 3 beers/day)
- •Being legally incapacitated, having significant emotional problems at the time of the study
研究组 & 干预措施
B
Placebo Comparator
干预措施: Placebo (Drug)
A
Active Comparator
ChAgly CD3
干预措施: ChAgly CD3 (Drug)
结局指标
主要结局
The difference in change in daily insulin need between baseline and month 48, between placebo and ChAgly CD3 treated patients
时间窗: 48 months
次要结局
未报告次要终点
研究者
研究点 (5)
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