NCT02271347

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 2, 2015

Status Verified

October 1, 2014

Enrollment Period

3 months

First QC Date

October 7, 2014

Last Update Submit

January 30, 2015

Conditions

Ebola Virus

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

    4 weeks

Study Arms (1)

CMX001

EXPERIMENTAL

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

Drug: CMX001

Interventions

CMX001DRUG

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

Also known as: Brincidofovir
CMX001

Eligibility Criteria

Age2 Months - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

brincidofovir
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 22, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 2, 2015

Record last verified: 2014-10