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Clinical Trial Summary

This study was designed to assess the safety and efficacy of preemptive treatment with oral brincidofovir (BCV), as compared to placebo, for the prevention of adenovirus (AdV) disease in recipients of hematopoietic stem cell transplantation (HCT) with asymptomatic AdV viremia.


Clinical Trial Description

This was a Phase 2, randomized, multicenter, placebo-controlled study for pediatric and adult subjects who had undergone hematopoietic stem cell transplantation (HCT) and who had been identified as having asymptomatic adenovirus (AdV) viremia [i.e., had detectable AdV DNA in plasma based on polymerase chain reaction testing performed at the local laboratory with no AdV disease symptoms]. The primary objectives of the study were to assess the safety and tolerability of oral brincidofovir (BCV), and to estimate the treatment failure rate based on an efficacy endpoint with 2 different dosing regimens of oral BCV versus placebo. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01241344
Study type Interventional
Source Chimerix
Contact
Status Completed
Phase Phase 2
Start date November 2010
Completion date June 2013

See also
  Status Clinical Trial Phase
Completed NCT04056546 - Interest of Rapid Typing in Adenovirus Infections.