An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola

Phase 2

Withdrawn

• Conditions: Ebola Virus Disease
• Interventions: Drug: Brincidofovir

• Registration Number: NCT04268966
• Lead Sponsor: Chimerix

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2020-02
• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-13
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CMX001	Brincidofovir	Initial dose of 200mg followed by 4 doses of 100mg

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD	8 weeks

Secondary Outcome Measures

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