NCT00797706Unknown1 期
A Phase I/II Double-Blind, Dose Ranging, Vehicle Controlled, Randomized, Parallel Groups, Safety, Tolerability and Efficacy Study of CHRONSEAL® (5-amino-acid Deleted Recombinant Human Hepatocyte Growth Factor (KP-dHGF)), in Subjects With Venous Leg Ulcers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 75
- 试验地点
- 16
- 主要终点
- To investigate safety and local tolerance of CHRONSEAL® cream containing 2 different concentrations of API, applied at 3 occasions every second day in chronic venous leg ulcers compared to vehicle.
研究概览
简要总结
The purpose of this study is to evaluate if the investigational medicinal product CHRONSEAL intended for future treatment of chronic venous leg ulcers is safe and tolerated and if it has an ulcer size reduction effect when administered to individuals suffering from venous leg ulcers.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vehicle
Placebo Comparator
干预措施: CHRONSEAL (Drug)
Low dose
Experimental
干预措施: CHRONSEAL (Drug)
High dose
Experimental
干预措施: CHRONSEAL (Drug)
结局指标
主要结局
To investigate safety and local tolerance of CHRONSEAL® cream containing 2 different concentrations of API, applied at 3 occasions every second day in chronic venous leg ulcers compared to vehicle.
时间窗: From start of treatment to 12 weeks post treatment
次要结局
- To investigate the treatment effect on ulcer area reduction and changes of ulcer condition of CHRONSEAL® cream, containing 2 different concentrations API, applied at 3 occasions every second day in chronic venous leg ulcers compared to vehicle.(From start of treatment to 12 weeks post treatment)
研究者
研究点 (16)
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