Back to resultsAn Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola (BCV EBOV)
Primary Purpose
Ebola Virus Disease
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Brincidofovir
Sponsored by
About this trial
This is an interventional treatment trial for Ebola Virus Disease
Eligibility Criteria
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:
-
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CMX001
Arm Description
Initial dose of 200mg followed by 4 doses of 100mg
Outcomes
Primary Outcome Measures
The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD
Secondary Outcome Measures
To assess the effect of BCV treatment on development of EVD in subjects through 21 days post-initiation of BCV therapy
Full Information
NCT ID
NCT04268966
First Posted
February 12, 2020
Last Updated
February 24, 2020
Sponsor
Chimerix
Collaborators
Food and Drug Administration (FDA)
1. Study Identification
Unique Protocol Identification Number
NCT04268966
Brief Title
An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chimerix
Collaborators
Food and Drug Administration (FDA)
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ebola Virus Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CMX001
Arm Type
Experimental
Arm Description
Initial dose of 200mg followed by 4 doses of 100mg
Intervention Type
Drug
Intervention Name(s)
Brincidofovir
Other Intervention Name(s)
CMX001
Primary Outcome Measure Information:
Title
The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
To assess the effect of BCV treatment on development of EVD in subjects through 21 days post-initiation of BCV therapy
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
12. IPD Sharing Statement
Learn more about this trial
An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola
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