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

Chimerix

Status and phase: Withdrawn; Phase 2

Conditions: Ebola Virus Disease

Treatments: Drug: Brincidofovir

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT04268966

CMX001-206

Details and patient eligibility

About

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 description

The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

CMX001

Experimental group

Description:

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

Treatment:

Drug: Brincidofovir