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

NCT ID: NCT04268966

Last Updated: 2020-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Ebola Virus Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CMX001

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

Group Type EXPERIMENTAL

Brincidofovir

Intervention Type DRUG

Interventions

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Brincidofovir

Intervention Type DRUG

Other Intervention Names

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CMX001

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Food and Drug Administration (FDA)

FED

Sponsor Role collaborator

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CMX001-206

Identifier Type: -

Identifier Source: org_study_id

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