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The Chimerix CMX001 Registry (CMX001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02167685
Recruitment Status : Terminated (terminated due to low enrollment rate)
First Posted : June 19, 2014
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Chimerix

Tracking Information
First Submitted Date June 17, 2014
First Posted Date June 19, 2014
Last Update Posted Date May 17, 2019
Study Start Date January 2014
Actual Primary Completion Date May 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 31, 2017)
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
Original Primary Outcome Measures
 (submitted: June 17, 2014)
Time to all-cause mortality [ Time Frame: 3 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
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Chimerix CMX001 Registry
Official Title A Prospective Observational Study for the Long-term Follow-up of Subjects Previously Enrolled in Selected Clinical Studies of CMX001.
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 Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects previously enrolled in selected clinical studies of CMX001
Condition
  • Outcomes
  • Survival Rates
Intervention Drug: CMX001
Other Name: Brincidofovir
Study Groups/Cohorts CMX001
Subjects who have previously participated in CMX001-301 or other CMX001 study.
Intervention: Drug: CMX001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Estimated Enrollment
 (submitted: June 17, 2014)
550
Original Estimated Enrollment Same as current
Actual Study Completion Date May 10, 2019
Actual Primary Completion Date May 10, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02167685
Other Study ID Numbers CMX001-333
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Chimerix
Original Responsible Party Same as current
Current Study Sponsor Chimerix
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Chimerix
Verification Date May 2019