The Chimerix CMX001 Registry (CMX001)
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ClinicalTrials.gov Identifier: NCT02167685 |
Recruitment Status :
Terminated
(terminated due to low enrollment rate)
First Posted : June 19, 2014
Last Update Posted : May 17, 2019
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Condition or disease | Intervention/treatment |
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Outcomes Survival Rates | Drug: CMX001 |
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 |
Actual Primary Completion Date : | May 10, 2019 |
Actual Study Completion Date : | May 10, 2019 |
Group/Cohort | Intervention/treatment |
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CMX001
Subjects who have previously participated in CMX001-301 or other CMX001 study.
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Drug: CMX001
Other Name: Brincidofovir |
- 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

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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 |
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:
- None

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

Responsible Party: | Chimerix |
ClinicalTrials.gov Identifier: | NCT02167685 |
Other Study ID Numbers: |
CMX001-333 |
First Posted: | June 19, 2014 Key Record Dates |
Last Update Posted: | May 17, 2019 |
Last Verified: | May 2019 |
Brincidofovir Antiviral Agents Anti-Infective Agents |