This is a randomized, controlled, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetic (PK), and adenovirus (AdV) antiviral activity of multiple ascending doses of IV brincidofovir (BCV). Approximately 30 eligible subjects will be sequentially enrolled into 1 of 3 planned cohorts. Within each cohort, subjects will be randomized in a 4:1 ratio to receive IV BCV dosed twice weekly (BIW) (on Days 1, 4, 8, and 11) or to receive investigator-assigned standard of care (SoC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Subjects will receive BCV administered as a continuous IV infusion over 2 hours twice weekly (on Days 1, 4, 8, and 11) for a period of 2 weeks (total of 4 doses).
Subjects randomized to the SoC in each cohort will be managed per local institutional guidelines and investigator judgement. SoC treatment options may include, but are not limited to, taking a "watch and-wait" approach, with or without decreased immunosuppression (i.e., no active treatment), or treatment with IV CDV, ganciclovir, or ribavirin.
UCLA Medical Center
Los Angeles, California, United States
University of Chigago
Chicago, Illinois, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
MD Anderson Cancer Center
Houston, Texas, United States
Plasma area under the curve (AUC) of BCV
BCV AUC will be determined by analysis of BCV plasma concentrations at the following time points after the start of Dose 1 and Dose 4: 30 minutes, and 2.5, 3, 4, 8, 10, 12, 36, and 72 hours
Time frame: 15 days
Plasma Cmax of BCV
BCV Cmax will be determined by analysis of BCV plasma concentrations at the following time points after the start of Dose 1 and Dose 4: 30 minutes, and 2.5, 3, 4, 8, 10, 12, 36, and 72 hours
Time frame: 15 days
Incidence (number and percentage of subjects) of treatment-emergent adverse events
Time frame: 22 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University Vita-Salute San Raffaele. San Faffaele Scientific Institute
Milan, Italy
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, Spain
Hospital Universitari I Politecnic la Fe
Valencia, Spain