NCT06625931已完成3 期
A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 Versus NTCB-P in Patients Who Require Parenteral Nutrition
Yuhan Corporation7 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Occurance rate of adverse drug reaction
研究概览
简要总结
A Randomized, Open-labeled, Multi-center, Active-controlled, Parallel-group Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 versus NTCB-P in patients who require parenteral nutrition
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who are 19 years old or older at the screening visit
- •Patients are expected to require PN for more than 3 days
- •Patients who voluntarily signed the consent form
排除标准
- •Patients are expected difficult to survive more than 3 days
- •Patients BMI is over 30 kg/m2
- •Patients having hypersensitivity to any peanut-, fish-, soy-, egg protein, or investigational drug
- •Patients with difficult peripheral intravenous line
- •Patients judged to be unsuitable for this trial by investigators
研究组 & 干预措施
NTCB01-1
Experimental
干预措施: NTCB01-1 (Drug)
NTCB-P
Active Comparator
干预措施: NTCB-P (Drug)
结局指标
主要结局
Occurance rate of adverse drug reaction
时间窗: Day 1 to day 4
次要结局
未报告次要终点
研究者
研究点 (7)
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