This randomized, open-label, parallel group, two-arm, multi-center assessment will compare IV BCV with IV CDV in adult and pediatric allogeneic HCT recipients with AdV viremia. A virologic response-driven approach to duration of treatment will be evaluated, in which randomized subjects are treated with either BCV or CDV until AdV viremia is confirmed as undetectable or until a maximum of 12 weeks of therapy, whichever occurs first. All subjects will be followed for a total of 24 weeks post-randomization, regardless of treatment assignment. Subjects will be assessed on a weekly basis through the end of treatment visit (EOT). Additional assessments will be performed at the test of cure (TOC) visit, which is 4 weeks after the last dose of study drug and at Weeks 12 and 24 post W1D1.
Male and female, post-allo HCT within last 180 days, aged 2 months and older at time of signing informed consent form.
Subject/Guardian willing and able to understand and provide written informed consent to participate in the study.
In the investigator's judgement, the subject's clinical condition justifies treatment with IV BCV or IV CDV for AdV infection.
AdV viremia DNA ≥10,000 IU/mL, OR
Subject received an allo-HCT with a matched sibling donor
Subject received more than 5 mg/kg of CDV for any reason in the 21 days prior to first dose of study drug.
Subject is allergic or hypersensitive to IV BCV or IV CDV or any of their components.
Subject received anti-AdV-specific cell-based therapy within 3 weeks prior to W1D1 or an anti-AdV vaccine at any time.
Parallel
cidofovir
DrugCDV does not have a labeled indication for treating Adenovirus infection. CDV will be administered according to local guidelines and institutional standard of care practice.
Brincidofovir
DrugIntravenous
To assess efficacy of intravenous (IV) brincidofovir (BCV), compared with IV cidofovir (CDV), in subjects after allo-HCT with adenovirus (AdV) viremia.
The primary efficacy endpoint is defined as AdV virological success at W5D1. -Proportion of subjects with AdV virological success
To assess the efficacy and safety of IV BCV, and IV CDV, in subjects after allo-HCT with AdV viremia.
The proportion of subjects with overall success, as adjuducated by the EAC
To assess the efficacy and safety of IV BCV, and IV CDV, in subjects after allo-HCT with AdV viremia.
Incidence and severity of treatment-emergent adverse events (TEAEs).
To assess the efficacy and safety of IV BCV, and IV CDV, in subjects after allo-HCT with AdV viremia.
All cause mortality
BCV Plasma Concentrations will be collected, measured and reported
The drug level (BCV) in plasma will be measured and used to examine the variability in drug concentrations among patients within the study population (i.e., population pharmacokinetics analysis).
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