A Prospective Observational Study for the Long-term Follow-up of Subjects Previously Enrolled in Selected Clinical Studies of CMX001.
Overview
- Phase
- N/A
- Intervention
- CMX001
- Conditions
- Outcomes
- Sponsor
- Chimerix
- Enrollment
- 550
- Locations
- 51
- Primary Endpoint
- Time to all-cause mortality
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have previously completed study CMX001-301 through the Week 24 visit, or participated in another qualifying clinical study with CMX
- •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
- Not provided
Arms & Interventions
CMX001
Subjects who have previously participated in CMX001-301 or other CMX001 study.
Intervention: CMX001
Outcomes
Primary Outcomes
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