NCT02087306

Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus Infection

A Phase 3, Open-Label, Multicenter Study of the Safety and Efficacy of Brincidofovir (CMX001) in the Treatment of Early Versus Late Adenovirus Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 2 Months
• Healthy volunteers: Not accepted

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).

Conditions

• Adenovirus Infection

Interventions

Type	Name	Description
DRUG	Brincidofovir	BCV administered twice weekly, dose depending on weight.

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-06-01
• Completion: 2016-08-01
• First posted: 2014-03-14
• Last updated: 2021-08-13
• Results posted: 2021-08-13

Locations

33 sites across 1 country: United States