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

Jazz Pharmaceuticals

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Ebola Virus Disease

Interventions

BrincidofovirDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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: \-

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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