A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease (NCT02439970) | Clinical Trial Compass
TerminatedPhase 3
A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease
Stopped: Study was terminated early due to results from another CMX001 study
United States5 participantsStarted 2015-09
Plain-language summary
To compare the efficacy of oral brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV seronegative pretransplant and received a kidney from a CMV seropositive donor
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Were male or female kidney transplant recipients who were ≥18 years of age (subject to local law/practice for clinical trial participation) and ≤14 days following their first or second renal allograft.
✓. Were at high risk of cytomegalovirus (CMV) infection defined as CMV-seronegative recipients who have received an allograft from a CMV-seropositive donor.
✓. Had an estimated glomerular filtration rate of \>10 mL/min (Cockcraft-Gault equation) at screening based on local laboratory results.
✓. Were CMV viremia negative (i.e., "not detected") as measured by the desginated central virology laboratory using the Roche COBAS® AmpliPrep/COBAS® TaqMan® CMV Test no more than 5 days prior to subject randomization, and at all prior assessments performed since transplant under local standard of care.
✓. Were able to ingest, absorb, and tolerate tablets.
✓. If male, was willing to use an acceptable contraceptive method(s) throughout the duration of his participation in the study, i.e., through Week 52.
✓. If female of childbearing potential, i.e., not post menopausal or surgically sterile, was willing to use 2 acceptable contraceptive methods, 1 of which must have been a barrier method, throughout the duration of her participation in the study, i.e., through Week 52.
✓. Were willing and able to provide informed consent.
Exclusion criteria
✕. Weighed ≤50 kg (110 lbs) or ≥120 kg (265 lbs).
. Were pregnant or breastfeeding or intended to conceive during the study period (i.e., through Week 52).
✕. Received a stem cell transplant or a solid organ transplant other than a kidney transplant.
✕. Had suspected CMV disease (either syndrome or tissue-invasive disease) or detectable CMV viremia by the central virology laboratory prior to the first dose of study drug.
✕. Had a history of CMV disease (either syndrome or tissue-invasive disease) within 6 months prior to the first dose of study drug.
✕. Had an absolute neutrophil count of \<500 cells/μL, platelet count of \<25,000/μL, or hemoglobin of \<8 g/dL at screening.
✕. Had hypersensitivity (not including renal dysfunction or an eye disorder) to valganciclovir (vGCV), ganciclovir (GCV), cidofovir (CDV) or to brincidofovir (BCV) or their excipients.
✕. Received (or were anticipated to need treatment with) any of the following: