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- WITHDRAWN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