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An Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease (CMX)

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ClinicalTrials.gov Identifier: NCT02271347
Recruitment Status : Withdrawn (Suspended Development Program)
First Posted : October 22, 2014
Last Update Posted : February 2, 2015
Sponsor:
Information provided by (Responsible Party):
Chimerix

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.

Condition or disease Intervention/treatment Phase
Ebola Virus Drug: CMX001 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease
Study Start Date : October 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Experimental: CMX001
CMX001 administered as initial dose of 200mg then 100mg BIW for a total of 5 doses.
Drug: CMX001
CMX001 administered as initial dose of 200mg then 100mg BIW for a total of 5 doses.
Other Name: Brincidofovir




Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability. [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:


Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT02271347     History of Changes
Other Study ID Numbers: CMX001-205
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: October 2014

Additional relevant MeSH terms:
Virus Diseases
Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections
Antiviral Agents
Anti-Infective Agents