An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola
BCV EBOV
An Open-Label, Multicenter Study of the Safety and Tolerability of Brincidofovir (CMX001) for Post-Exposure Prophylaxis of Ebola Virus Disease
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2014
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 12, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedFebruary 26, 2020
February 1, 2020
1.1 years
February 12, 2020
February 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To assess the effect of BCV treatment on development of EVD in subjects through 21 days post-initiation of BCV therapy
8 weeks
Study Arms (1)
CMX001
EXPERIMENTALInitial dose of 200mg followed by 4 doses of 100mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jazz Pharmaceuticalslead
- Food and Drug Administration (FDA)collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2020
First Posted
February 13, 2020
Study Start
October 1, 2014
Primary Completion
November 1, 2015
Study Completion
December 1, 2015
Last Updated
February 26, 2020
Record last verified: 2020-02