Conditions: Adenovirus Infection
Keywords: Adenovirus Infection
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 201
Healthy volunteers: no

Brief summary:
This was a Phase 3 open-label, non-randomized, multicenter study of oral brincidofovir (BCV) administered twice weekly for the treatment of adenovirus (AdV) infection detected during asymptomatic AdV viremia or during symptomatic AdV infection.

Detailed description:
This was a Phase 3 open-label, non-randomized, multicenter study of the safety, tolerability, and efficacy of oral brincidofovir (BCV) when administered twice weekly for the treatment of disseminated adenovirus (AdV) disease and for the treatment of AdV infection when treatment was initiated in subjects who were at risk of progression to disseminated disease (i.e., during the asymptomatic or localized phases of infection).

Arms:
arm 1: Subjects who weighed \<50 kg received 2 mg/kg (not to exceed 100 mg) BCV twice weekly administered orally as the appropriate volume of 10-mg/mL liquid suspension.

Subjects who weighed ≥50 kg received 100 mg BCV twice weekly administered orally as one 100 mg tablet (or the appropriate volume of 10-mg/mL liquid suspension if unable to swallow solid medicine).

Interventions: intervention 1: Brincidofovir
Intervention descriptions: intervention 1: BCV administered twice weekly, dose depending on weight.

Protocol document: