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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2015

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

Interventions

  • Drug: Brincidofovir

Arms, Groups and Cohorts

  • Experimental: CMX001
    • Initial dose of 200mg followed by 4 doses of 100mg

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chimerix
  • Collaborator
    • Food and Drug Administration (FDA)
  • Provider of Information About this Clinical Study
    • Sponsor

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