The Chimerix CMX001 Registry (CMX001)

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2016 by Chimerix

Sponsor:

Information provided by (Responsible Party):

Chimerix

ClinicalTrials.gov Identifier:

NCT02167685

First received: June 17, 2014

Last updated: May 31, 2016

Last verified: May 2016

History of Changes

Purpose

The prospective observational study is to establish a registry database to evaluate the potential impact of prior treatment with CMX001 on the long-term incidence of specific events, such as outcomes, late CMV and other Double-stranded DNA virus associated events, s well as survival rates in subjects previously enrolled in selected clinical studies of CMX001. Each Registry participant will be followed for a period of approximately 3 years from their enrollment in the Registry.

Condition	Intervention
Outcomes Survival Rates	Drug: CMX001


Study Type:	Observational [Patient Registry]
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration:	3 Years
Official Title:	A Prospective Observational Study for the Long-term Follow-up of Subjects Previously Enrolled in Selected Clinical Studies of CMX001.

Further study details as provided by Chimerix:

Primary Outcome Measures:

Time to all-cause mortality [ Time Frame: 3 years ] [ Designated as safety issue: No ]
evaluate the potential impact of prior treatment with CMX001 on the long-term incidence of specific events, such as the development of new malignancies and late cytomegalovirus (CMV)-associated events, as well as survival rates in subjects previously enrolled in selected clinical studies of CMX001


Estimated Enrollment:	550
Study Start Date:	January 2014
Estimated Primary Completion Date:	December 2018 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
CMX001 Subjects who have previously participated in CMX001-301 or other CMX001 study.	Drug: CMX001 Other Name: Brincidofovir

Eligibility


Ages Eligible for Study:	6 Months to 100 Years (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects previously enrolled in selected clinical studies of CMX001

Criteria

Inclusion Criteria:

Have previously completed study CMX001-301 through the Week 24 visit, or participated in another qualifying clinical study with CMX001.
Willing and able to understand and provide written informed consent to participate in this observational study
Willing and able to participate in all required study activities for the entire duration of the observational study (i.e., agreeable to being contacted at periodic intervals over the course of approximately 3 years following the completion of study CMX001-301 or other qualifying clinical study.

Exclusion Criteria:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02167685

Contacts


Contact: Garrett Nichols, MD	919-806-1074	clinicaltrials@chimerix.com

Show 48 Study Locations

Sponsors and Collaborators

Chimerix

More Information


Responsible Party:	Chimerix
ClinicalTrials.gov Identifier:	NCT02167685 History of Changes
Other Study ID Numbers:	CMX001-333
Study First Received:	June 17, 2014
Last Updated:	May 31, 2016
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 26, 2016

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