KCT0001224已完成未知
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 Korea0 个研究点目标入组 68 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1. Signed informed consent
- •a. Subjects must have voluntarily signed and dated an IRB/IEC approved written
- •informed consent form in accordance with regulatory and institutional
- •guidelines, This must be obtained before the performance of any protocol
- •related procedures that are not part of normal subject care.
- •2. Target population
- •a. Subjects who need the pleurodesis among subjects diagnosed with a malignant
- •pleural effusion
- •b. Full lung expansion must be achieved within 12 to 24 hours after drainage.
- •c. Expected survival time of at least 2 months
- •d. Subjects who score 50 or more on the Karnofshy perfomance Scale.
排除标准
- •1. Subjects with previous attempts at pleurodesis with sclerosing agent
- •2. Subjects with trapped lung or bronchial obstruction
- •3. Subjects with adverse drug reponses to mistletoe agents
- •4. Subjects who have participated in another clinical study other than the
- •present study.
- •5. Subjects who is taking immune-suppressive agents
- •6. Subjects with medical and psychiatric contraindications for the study drug
- •7. Subjects who are not allowed to participate in the study by legal requirements
- •8. Subjects who are not allowed to participate in the study by the investigator's
- •discretion.
研究者
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