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

Ebola Virus Clinical Trial

— CMX  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02271347
• Other study ID #: CMX001-205
• Status: Withdrawn
• Phase: Phase 2
• First received: October 7, 2014
• Last updated: January 30, 2015
• Start date: October 2014
• Est. completion date: January 2015

Study information

• Verified date: October 2014
• Source: Chimerix
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ebola Virus
• Hemorrhagic Fever, Ebola
• Virus Diseases

Intervention

Drug:
• CMX001
CMX001 administered as initial dose of 200mg then 100mg BIW for a total of 5 doses.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chimerix

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability.		4 weeks	Yes