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WithdrawnNCT04268966BCV EBOVUpdated Feb 26, 2020

An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola

A Phase 2 interventional study of Brincidofovir in Ebola Virus Disease, sponsored by Chimerix. Withdrawn. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-02-26.

Sponsored by Chimerix · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Ebola Virus Disease
03

In context

Virus Diseases

914 studies on the registry are indexed under Virus Diseases; 110 are open to participants now.

Browse Virus Diseases studies →

Lead sponsor

Chimerix is the lead sponsor of 33 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

-

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    CMX001

    Initial dose of 200mg followed by 4 doses of 100mg

    Drug: Brincidofovir

Interventions

  • DrugBrincidofovir

    Also known as: CMX001

06

What researchers measure

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

    Time frame: 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

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04268966
Lead sponsor
Chimerix
Collaborators
Food and Drug Administration (FDA)
Responsible party
Sponsor
First posted
Feb 13, 2020
Start date
Oct 2014
Primary completion
Nov 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Feb 26, 2020
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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