Back to resultsAn Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease (CMX)
Primary Purpose
Ebola Virus
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CMX001
Sponsored by
About this trial
This is an interventional treatment trial for Ebola Virus
Eligibility Criteria
Inclusion Criteria:
- Positive for Ebola virus RNA in plasma
- Subject must be able to ingest, absorb, and tolerate oral medication
- Subject must be willing to use adequate contraception during their participation
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CMX001
Arm Description
CMX001 administered as initial dose of 200mg then 100mg BIW for a total of 5 doses.
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02271347
Brief Title
An Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease
Acronym
CMX
Official Title
An Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Suspended Development Program
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chimerix
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and tolerability of Brincidofovir (BCV) when administered as an initial 200mg dose followed by 100mg twice weekly (BIW) for a total of 5 doses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ebola Virus
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
CMX001 administered as initial dose of 200mg then 100mg BIW for a total of 5 doses.
Intervention Type
Drug
Intervention Name(s)
CMX001
Other Intervention Name(s)
Brincidofovir
Intervention Description
CMX001 administered as initial dose of 200mg then 100mg BIW for a total of 5 doses.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Positive for Ebola virus RNA in plasma
Subject must be able to ingest, absorb, and tolerate oral medication
Subject must be willing to use adequate contraception during their participation
Exclusion Criteria:
-
12. IPD Sharing Statement
Learn more about this trial
An Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease
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