- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02271347
An Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease (CMX)
January 30, 2015 updated by: Chimerix
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CMX001
CMX001 administered as initial dose of 200mg then 100mg BIW for a total of 5 doses.
|
CMX001 administered as initial dose of 200mg then 100mg BIW for a total of 5 doses.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
October 7, 2014
First Submitted That Met QC Criteria
October 20, 2014
First Posted (Estimate)
October 22, 2014
Study Record Updates
Last Update Posted (Estimate)
February 2, 2015
Last Update Submitted That Met QC Criteria
January 30, 2015
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMX001-205
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ebola Virus
-
National Institute of Allergy and Infectious Diseases...CompletedEbola Virus Disease | Ebola Hemorrhagic Fever | Ebola Virus Vaccines | Envelope Glycoprotein, Ebola Virus | FilovirusUnited States
-
National Institute of Allergy and Infectious Diseases...Completed
-
Institut National de la Santé Et de la Recherche...TerminatedEbola Virus SurvivorGuinea
-
National Institute of Allergy and Infectious Diseases...CompletedEbola VirusUnited States, Congo, The Democratic Republic of the
-
Makerere UniversityMRC/UVRI and LSHTM Uganda Research Unit; Ministry of Health, Uganda; Epicentre; Makerere University Lung Institute and other collaboratorsNot yet recruitingSudan Ebola Virus Vaccines
-
National Institute of Allergy and Infectious Diseases...US Military HIV Research ProgramCompleted
-
Merck Sharp & Dohme LLCUnited States Department of Defense; BioProtection Systems CorporationCompleted
-
Cerus CorporationTerminated
-
Jiangsu Province Centers for Disease Control and...Beijing Institute of Biotechnology; Tianjin Cansino Biotechnology IncCompletedEbola DiseaseSierra Leone
-
National Institute of Allergy and Infectious Diseases...CompletedEbola Virus Disease | Ebola Vaccines | Marburg Virus Disease | Marburgvirus | EbolavirusUnited States
Clinical Trials on CMX001
-
ChimerixFood and Drug Administration (FDA)Withdrawn
-
ChimerixTerminated
-
ChimerixCompletedAdenovirus InfectionUnited States
-
ChimerixCompletedHepatic ImpairmentUnited States
-
ChimerixNational Institutes of Health (NIH)CompletedHealthyUnited States
-
Emergent BioSolutionsCompleted
-
ChimerixCompletedDouble-stranded DNA VirusUnited States
-
ChimerixTerminated
-
ChimerixNo longer available