NCT03469167已完成不适用
Clinical Study to Evaluate Efficacy and Safety of "CEGP003(Wound Dressing Solution Containing EGF)" for Achieving Hemostasis and Protecting Ulcer in Patients With Acute Peptic Ulcer Bleeding: A Prospective, Randomized Trial
CGBio Inc.0 个研究点目标入组 76 人开始时间: 2014年10月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 主要终点
- Initial hemostasis rate
研究概览
简要总结
This is a prospective, single-blinded, randomized study to evaluate the efficacy and safety of CEGP003 in patients with acute peptic ulcers bleeding, compared to endoscopic epinephrine injection therapy.
详细描述
CEGP003 is wound dressing solution containing Hydroxyethyl-cellulose and EGF. Epidermal growth factor (EGF) stimulates cell growth and differentiation by binding to its receptor, which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a peptic ulcers bleeding.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)
排除标准
- •Subjects who have a history of malignant tumor in upper gastro-intestinal site
- •Subjects with platelet and coagulation dysfunction (PLT < 50E9/L, INR > 2)
- •Subjects that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 72 hours after the treatment
- •Subjects with one or more bleeding sources
- •Subjects who are pregnant or breast-feeding
- •Subject who are allergic or have a hypersensitive reaction to Hydroxyethyl-cellulose or EGF
- •Subjects who have undergone endoscopically therapies within the last 7 days
- •Subjects who are considered not suitable for the study by significant disease
- •Subjects who are not able to comply with the study requirements
- •Subjects who are currently enrolled in another clinical study which can impact the study within 30 days of screening
- •Subjects who are considered not suitable for the study by the investigator
结局指标
主要结局
Initial hemostasis rate
时间窗: Within 10 minutes after first endoscopy session
Endoscopically verified cessation of bleeding for at least 10 minutes after treatment.
次要结局
- Usability for the delivery system(0 day)
- Recurrent bleeding rate(Within 72 hours)
- Wound healing effect of peptic ulcer(After 3 days (72 hours))
- Time required for treatment(0 day)
研究者
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