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

February 24, 2020 updated by: Chimerix

An Open-Label, Multicenter Study of the Safety and Tolerability of Brincidofovir (CMX001) for Post-Exposure Prophylaxis of Ebola Virus Disease

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

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

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

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
Initial dose of 200mg followed by 4 doses of 100mg
Drug: Brincidofovir
Other Names:
  • CMX001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chimerix

Collaborators

Food and Drug Administration (FDA)

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 (Anticipated)

November 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

February 12, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 13, 2020

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMX001-206

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.

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