Phase III, Open-labeled, Multicenter Study of the Safety and Efficacy of Brincidofovir (CMX001) in the Treatment of Early Versus Late Adenovirus Infection
This is a multicenter study of Brincidofovir (CMX001) (BCV) administered twice weekly (BIW)
for the treatment of AdV infection detected during asymptomatic AdV viremia or during
symptomatic AdV infection. After completing a screening assessment to confirm study
eligibility, all enrolled subjects will undergo a treatment period of 12 weeks. Beginning on
Day 1, adult (≥ 18 years) and adolescent (13-17 years) subjects weighing > 50 kg will
receive BCV 100 mg BIW; children up to 12 years of age will receive weight-based doses of 2
mg/kg BIW, not-to-exceed a total dose of 200 mg/week.
The prospective observational study is to establish a registry database to evaluate the
potential impact of prior treatment with CMX001 on the long-term incidence of specific
events, such as outcomes, late CMV and other Double-stranded DNA virus associated events, s
well as survival rates in subjects previously enrolled in selected clinical studies of
CMX001. Each Registry participant will be followed for a period of approximately 3 years
from their enrollment in the Registry.
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