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NCT04268966 Clinical Trial

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

Ebola Virus Disease Clinical Trial

— BCV EBOV  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04268966
Other study ID # CMX001-206
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date October 2014
Est. completion date December 2015

Study information
Verified date February 2020
Source Chimerix
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Brincidofovir

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Chimerix Food and Drug Administration (FDA)

Outcome
Type Measure Description Time frame Safety issue
Primary 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 To assess the effect of BCV treatment on development of EVD in subjects through 21 days post-initiation of BCV therapy 8 weeks
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