Clinical Trial: Phase III, Open-labeled, Multicenter Study of the Safety and Efficacy of Brincidofovir (CMX001) in the Treatment of Early Versus Late Adenovirus Infection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Chimerix

Current Primary Outcome: To compare the overall mortality at Week 24 of subjects treated with BCV during asymptomatic adenovirus (AdV) viremia or "early" AdV infection to the mortality at Week 24 for subjects treated with BCV during symptomatic or "late" AdV disease [ Time Frame: 24 weeks ]

To compare the overall mortality at Week 24 of subjects treated with BCV during asymptomatic adenovirus (AdV) viremia or "early" AdV infection to the mortality at Week 24 for subjects treated with BCV during symptomatic or "late" AdV disease


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Chimerix

Dates:
Date Received: March 12, 2014
Date Started: March 2014
Date Completion:
Last Updated: November 10, 2016
Last Verified: August 2015