临床试验/NCT02271347

NCT02271347撤回2 期

An Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease

Chimerix0 个研究点开始时间: 2014年10月最近更新: 2015年2月2日

适应症

干预措施

试验速览

阶段: 2 期
状态: 撤回
发起方: Chimerix
主要终点: Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the safety and tolerability of Brincidofovir (BCV) when administered as an initial 200mg dose followed by 100mg twice weekly (BIW) for a total of 5 doses.

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: 2 Months 至 75 Years（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Positive for Ebola virus RNA in plasma
•Subject must be able to ingest, absorb, and tolerate oral medication
•Subject must be willing to use adequate contraception during their participation

排除标准

未提供

研究组 & 干预措施

CMX001

Experimental

CMX001 administered as initial dose of 200mg then 100mg BIW for a total of 5 doses.

干预措施: CMX001 (Drug)

结局指标

主要结局

Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

时间窗: 4 weeks

次要结局

未报告次要终点

研究者

发起方

Chimerix

申办方类型

Industry

责任方

Sponsor

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