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The Chimerix CMX001 Registry (CMX001)

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ClinicalTrials.gov Identifier: NCT02167685
Recruitment Status : Recruiting
First Posted : June 19, 2014
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Chimerix

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Outcomes Survival Rates Drug: CMX001

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 550 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: A Prospective Observational Study for the Long-term Follow-up of Subjects Previously Enrolled in Selected Clinical Studies of CMX001.
Study Start Date : January 2014
Estimated Primary Completion Date : December 2025
Groups and Cohorts
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Group/Cohort Intervention/treatment
CMX001
Subjects who have previously participated in CMX001-301 or other CMX001 study.
 Drug: CMX001
Other Name: Brincidofovir


Outcome Measures
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Primary Outcome Measures :
  1. Time to all-cause mortality [ Time Frame: 10 years ]
    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


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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 10 years following the completion of study CMX001-301 or other qualifying clinical study.

Exclusion Criteria:

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167685


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

  Show 51 Study Locations
Sponsors and Collaborators
Chimerix
More Information
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Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT02167685     History of Changes
Other Study ID Numbers: CMX001-333
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017