A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus
|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: NCT02439957|
Recruitment Status : Terminated (Study terminated early due to results from another CMX001 study.)
First Posted : May 12, 2015
Results First Posted : July 16, 2021
Last Update Posted : July 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cytomegalovirus Disease Kidney Transplant Infection||Drug: Brincidofovir Drug: Valganciclovir||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Study to Assess Efficacy, Safety, and Tolerability of Brincidofovir Versus Valganciclovir for Prevention of Cytomegalovirus (CMV) Disease in CMV-Seropositive Kidney Transplant Recipients Who Received Antilymphocyte Induction Therapy|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||May 15, 2016|
|Actual Study Completion Date :||July 31, 2016|
Active Comparator: Treatment 1
100 mg brincidofovir (BCV; one 100 mg tablet) twice weekly plus valganciclovir (vGCV) placebo (2 tablets) once daily.
Active Comparator: Treatment 2
900 mg valanciclovir (vGCV; two 450 tablets) once daily plus brincidofovir (BCV) placebo (1 tablet) twice weekly.
Other Name: vGCV
- The Incidence of Cytomegalovirus (CMV) Disease [ Time Frame: 24 weeks (±14 days) ]
The incidence of CMV disease, which included CMV tissue-invasive disease and CMV syndrome, occurring anytime between randomization and Week 24 posttransplant (±14 days).
The proportion of subjects who met this failure endpoint were to be compared between brincidofovir (BCV) and valganciclovir (vGCV) using an unadjusted 95% confidence interval (CI) of the absolute difference between groups (BCV minus vGCV). Number of failures and failure rates were to be presented for each treatment. If the upper bound of the 95% CI fell below 10%, BCV would have demonstrated non-inferiority to vGCV. In the event that the upper bound of the 95% CI fell below 0%, BCV would have additionally demonstrated superiority over vGCV.
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): NCT02439957
|United States, California|
|St. Vincent Medical Center|
|Los Angeles, California, United States, 90057|
|United States, Colorado|
|University of Colorado Hospital/Health Science Center|
|Aurora, Colorado, United States, 80045|
|United States, Connecticut|
|Yale New Haven Hospital|
|New Haven, Connecticut, United States, 06520|