A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease — SUSTAIN  

Cytomegalovirus Disease Clinical Trial

Official title: SUSTAIN: A Randomized, Double-Blind, Multicenter, Phase 3 Study of the Efficacy, Safety, and Tolerability of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease in High-Risk Kidney Allograft Recipients

Status Terminated

Clinical Trial Summary

To compare the efficacy of oral brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV seronegative pretransplant and received a kidney from a CMV seropositive donor

Clinical Trial Description

This was a randomized, double-blind, double-dummy, parallel-group, multicenter study of the efficacy, safety, and tolerability of oral BCV versus vGCV for the prevention of CMV disease in high-risk kidney transplant allograft recipients, defined as CMV-seronegative recipients (R-) receiving a CMV-seropositive graft (D+). The study comprised a screening evaluation period (up to 14 days posttransplant), a treatment period (up to 28 weeks posttransplant), and a posttreatment follow-up period (24 weeks, through Week 52 posttransplant). ;

Related Conditions & MeSH terms

• Cytomegalovirus Disease
• Cytomegalovirus Infections

• NCT number: NCT02439970
• Study type: Interventional
• Source: Chimerix
• Status: Terminated
• Phase: Phase 3
• Start date: September 2015
• Completion date: January 30, 2016