Ebola Virus Disease Clinical Trial
— BCV EBOVOfficial title:
An Open-Label, Multicenter Study of the Safety and Tolerability of Brincidofovir (CMX001) for Post-Exposure Prophylaxis of Ebola Virus Disease
Verified date | February 2020 |
Source | Chimerix |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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: - |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chimerix | Food and Drug Administration (FDA) |
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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