A Study of the Safety and Efficacy of CMX001 for the Prevention of CMV Infection in CMV-seropositive HCT Recipients
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|ClinicalTrials.gov Identifier: NCT01769170|
Recruitment Status : Completed
First Posted : January 16, 2013
Results First Posted : January 5, 2021
Last Update Posted : July 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|CMV||Drug: Brincidofovir Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||452 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3 Study of the Safety, Tolerability, and Efficacy of CMX001 for the Prevention of Cytomegalovirus (CMV) Infection in CMV-seropositive (R+) Hematopoietic Stem Cell Transplant Recipients|
|Actual Study Start Date :||August 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||January 2016|
Placebo Comparator: Placebo
Matching placebo administered orally twice weekly
Active Comparator: Brincidofovir
100 mg brincidofovir administered orally twice weekly
- Number of Participants With Clinically Significant CMV Infection Through Week 24 Post-Transplant [ Time Frame: 24 weeks ]
Clinically significant cytomegalovirus (CMV) infection was defined by either of the following outcomes:
- Onset of CMV end-organ disease; or
- Initiation of anti-CMV-specific preemptive therapy based on documented CMV viremia (as measured by the central virology laboratory) and the clinical condition of the subject.
CMV viremia (i.e., the measurement of CMV DNA in plasma) was determined by the designated central virology laboratory at all scheduled visits via quantitative polymerase chain reaction (qPCR) testing using the Roche COBAS® AmpliPrep/COBAS® TaqMan® CMV Test.
- Incidence of Clinically Significant CMV Infection Through Week 14 [ Time Frame: 14 weeks ]
The incidence of clinically significant cytomegalovirus (CMV) infection through Week 14.
Blood and urine for virologic evaluations were collected at screening, pre-dose on the first day of study drug administration, and at pre-specified intervals throughout the treatment phases of the study and sent to a designated central virology laboratory for analysis. Blood samples were used for real-time assay of CMV viremia in plasma using a qPCR assay. Urine samples were stored for possible future retrospective analyses of CMV.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769170