NCT02191540已完成3 期
A Phase 3, Multi-Center, Single-Arm, Open-Label Study For The Safety And Efficacy Of Mistletoe Extract (AbnobaViscum® Injection) In Malignant Pleural Effusions
Abnoba Korea3 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2011年1月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 3
- 主要终点
- Efficacy
研究概览
简要总结
Phase 3, non-randomized, Multicenter, single arm study to assess efficacy and safety of Abnoba viscum F 20mg in patients with malignant pleural effusion
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who need the pleurodesis among subjects diagnosed with a mlignant pleural effusion
- •Full lung expansion must be achieved within 12 to 24 hours after drainage
- •Expected survival time of at least 2 months
- •Subject who score 50 or more on the Karnofsky Performance Scale
排除标准
- •Subjects with previous attempts at pleurodesis with sclerosing agent
- •Subjects with trapped lung or bronchial obstruction
- •Subjects with adverse drug response to mistletoe agents
- •Subjects who have participated in another clinical study other than the present study
- •Subjects who is taking immune-suppressive agents
- •Subjects with medical and psychiatric contraindications for the study drug
- •Subjects who are not allowed to participate in the study by legal requirement
- •Subjects who are not allowed to participate in the study by the Investigator's discretion
研究组 & 干预措施
Abnoba Viscum F 20mg
Experimental
干预措施: Abnoba Viscum F 20mg (Drug)
结局指标
主要结局
Efficacy
时间窗: 4 weeks
Efficacy assessment of pleural effusion with Chest X-ray after 4 weeks of final treatment
次要结局
未报告次要终点
研究者
研究点 (3)
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