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.
Brief Title
The Chimerix CMX001 Registry
Categories
Completion Date
Completion Date Type
Actual
Conditions
Outcomes
Survival Rates
Eligibility 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:
* None
* 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
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
100 Years
Minimum Age
6 Months
NCT Id
NCT02167685
Org Class
Industry
Org Full Name
Chimerix
Org Study Id
CMX001-333
Overall Status
Terminated
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Prospective Observational Study for the Long-term Follow-up of Subjects Previously Enrolled in Selected Clinical Studies of CMX001.
Primary Outcomes
Outcome Description
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
Outcome Measure
Time to all-cause mortality
Outcome Time Frame
10 years
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Subjects previously enrolled in selected clinical studies of CMX001
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
100
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Deepa Manwani
Investigator Email
dmanwani@montefiore.org
Investigator Phone
718-741-2342
MeSH Terms
BRINCIDOFOVIR