jRCTs031220565已完成不适用
Single arm intervention study to test the efficacy of REGN-EB3 against Ebola hemorrhagic fever (REGN-EVD)
未提供0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- No limit 至 No limit（—）
- 性别
- All
入选标准
- •(1) Persons who have given written consent to participate in the research.
- •However, those who meet the conditions described in 18.2 may participate in this research without prior consent.
- •(1) There is an immediate and obvious danger to the life of the person who is to be the subject of the specified clinical research.
- •(2) Other treatment methods cannot be expected to be sufficiently effective (even if they can be expected to be as effective as ordinary medical treatment or life-saving treatment, etc.).
- •(iii) That the Specific Clinical Research to be conducted is not in the best interests of the subject of the Clinical Research.
- •(iii) It is recognized that there is a sufficient possibility of avoiding a risk to life by conducting the said Specified Clinical Research.
- •(iii) The possibility of avoiding a life-threatening situation by conducting the specified clinical research is considered sufficient.
- •(iv) The anticipated disadvantages to the subjects of the Specified Clinical Research are the minimum necessary.
- •(iv) The anticipated disadvantages to the person who should be the subject of the specified clinical research are the minimum necessary.
- •(v) It is not possible to immediately contact the person who is to be the surrogate.
- •When the situation becomes such that the subject of the clinical research and the surrogate can be explained, an explanation of the said clinical research should be given promptly and consent should be obtained in writing.
- •Persons whose EV RNA is detected by reverse-transcriptase-polymerase-chain-reaction assay (RT-PCR) test using blood, urine, or throat swab samples
排除标准
- •Subjects deemed inappropriate for inclusion in the study by the Principal Investigator or Research Supervisor
- •Patients for whom administration of the drug is considered inappropriate based on the attached document or other documents equivalent to the investigational new drug summary
- •Patients with a history of serious hypersensitivity to this drug
结局指标
主要结局
-
Mortality at 28 days after study inclusion
次要结局
- Mortality(14 and 56 days after inclusion)
- Virus levels in blood(1, 3, 7, 10, 14 and 28 days after inclusion)
- Virus levels in semen(28 and 56 days after study entry)
- Incidence of adverse events
研究者
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