An Open-Label Study , Safety and Tolerability of Brincido... | NCT04268966

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

NCT04268966

Sponsor

Jazz Pharmaceuticals

Status

Withdrawn

Last Update Posted

Feb 26, 2020Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Ebola Virus Disease

Interventions

Brincidofovir

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Nov 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Feb 12, 2020

First Submission Date that Met QC Criteria

Feb 12, 2020

First Posted Date

Feb 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2020

Last Update Posted Date

Feb 26, 2020Actual

Name	Class
Food and Drug Administration (FDA)	FED

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CMX001	Experimental	Initial dose of 200mg followed by 4 doses of 100mg	Drug: Brincidofovir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brincidofovir	Drug		CMX001	CMX001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
To assess the effect of BCV treatment on development of EVD in subjects through 21 days post-initiation of BCV therapy		8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019142	Hemorrhagic Fever, Ebola

Ancestor Terms

ID	Term
D006482	Hemorrhagic Fevers, Viral
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C525733	brincidofovir

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided