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

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

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04268966
Acronym
BCV EBOV
Enrollment
0
Registered
2020-02-13
Start date
2014-10-31
Completion date
2015-12-31
Last updated
2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ebola Virus Disease

Brief summary

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

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

Interventions

Sponsors

Food and Drug Administration (FDA)
CollaboratorFED
Jazz Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD8 weeks

Secondary

MeasureTime frame
To assess the effect of BCV treatment on development of EVD in subjects through 21 days post-initiation of BCV therapy8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026