An Open-Label, Multicenter Study of the Safety and Anti V... | NCT02271347

Studies
An Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease

NCT02271347

Sponsor

Jazz Pharmaceuticals

Status

Withdrawn

Last Update Posted

Feb 2, 2015Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Ebola Virus

Interventions

CMX001

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

Oct 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Suspended Development Program

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Oct 7, 2014

First Submission Date that Met QC Criteria

Oct 20, 2014

First Posted Date

Oct 22, 2014Estimated

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

Jan 30, 2015

Last Update Posted Date

Feb 2, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the safety and tolerability of Brincidofovir (BCV) when administered as an initial 200mg dose followed by 100mg twice weekly (BIW) for a total of 5 doses.

Detailed Description

Not provided

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	CMX001 administered as initial dose of 200mg then 100mg BIW for a total of 5 doses.	Drug: CMX001

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CMX001	Drug	CMX001 administered as initial dose of 200mg then 100mg BIW for a total of 5 doses.	CMX001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.		4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Positive for Ebola virus RNA in plasma
Subject must be able to ingest, absorb, and tolerate oral medication
Subject must be willing to use adequate contraception during their participation

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C525733	brincidofovir

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided