临床试验/NCT04268966

NCT04268966撤回2 期

An Open-Label, Multicenter Study of the Safety and Tolerability of Brincidofovir (CMX001) for Post-Exposure Prophylaxis of Ebola Virus Disease

Chimerix0 个研究点开始时间: 2014年10月最近更新: 2020年2月26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: The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD

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 determine how safe and tolerable Brincidofovir (BCV) is when given for post exposure prophylaxis of Ebola virus disease.

详细描述

The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD

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: 18 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Individuals have high-risk exposure to Ebola Virus based on CDC definitions
•Must be able to ingest, absorb and tolerate oral medication
•As appropriate, must be willing to use adequate methods of contraception during the study and at least 6 months after their last dose of BCV

排除标准

未提供

研究组 & 干预措施

CMX001

Experimental

Initial dose of 200mg followed by 4 doses of 100mg

干预措施: Brincidofovir (Drug)

结局指标

主要结局

The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD

时间窗: 8 weeks

次要结局

To assess the effect of BCV treatment on development of EVD in subjects through 21 days post-initiation of BCV therapy(8 weeks)

研究者

发起方

Chimerix

申办方类型

Industry

责任方

Sponsor

相似试验

撤回

2 期

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

NCT02271347Chimerix

已完成

3 期

Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus InfectionAdenovirus Infection

NCT02087306Chimerix201

撤回

3 期

Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for the Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 (P08599)Chronic Hepatitis C

NCT01641666Merck Sharp & Dohme LLC

已完成

3 期

Study to Assess Brincidofovir Treatment of Serious Diseases or Conditions Caused by Double-stranded DNA VirusesDouble-stranded DNA Virus

NCT01143181Chimerix210

已完成

2 期

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With EpilepsyEpilepsy

NCT03405714UCB Biopharma S.P.R.L.50