Outcomes, Survival Rates
Conditions
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.
Interventions
DRUGCMX001
Sponsors
Jazz Pharmaceuticals
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to all-cause mortality | 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 |
Countries
Belgium, Canada, United States
Outcome results
None listed