The Chimerix CMX001 Registry
- Registration Number
- NCT02167685
- Lead Sponsor
- Chimerix
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 550
- 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.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CMX001 CMX001 Subjects who have previously participated in CMX001-301 or other CMX001 study.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (51)
University of California San Diego
🇺🇸La Jolla, California, United States
St. Vincent Medical Center
🇺🇸Los Angeles, California, United States
Children's Hospital of LA
🇺🇸Los Angeles, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
Childrens Hospital of Colorado
🇺🇸Aurora, Colorado, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
University of Colorado Hospital/Health Science Center
🇺🇸Aurora, Colorado, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Scroll for more (41 remaining)University of California San Diego🇺🇸La Jolla, California, United States