NCT02439957

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

Study to Assess Efficacy, Safety, and Tolerability of Brincidofovir Versus Valganciclovir for Prevention of Cytomegalovirus (CMV) Disease in CMV-Seropositive Kidney Transplant Recipients Who Received Antilymphocyte Induction Therapy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a randomized, double-blind, double-dummy, parallel-group, multicenter study of the efficacy, safety, and tolerability of oral brincidofovir (BCV) versus valganciclovir for the prevention of cytomegalovirus (CMV) disease in CMV-seropositive kidney transplant recipients who received antilymphocyte induction therapy.

Detailed description

This was a randomized, double-blind, double-dummy, parallel-group, multicenter study of the efficacy, safety, and tolerability of oral brincidofovir (BCV) versus valganciclovir for the prevention of cytomegalovirus (CMV) disease in CMV-seropositive kidney transplant recipients who received antilymphocyte induction therapy. The study comprised a screening evaluation period (up to 14 days posttransplant), a treatment period (up to 14 weeks posttransplant), and a posttreatment follow-up period (10 weeks, through Week 24 posttransplant).

Conditions

• Cytomegalovirus Disease
• Kidney Transplant Infection

Interventions

Type	Name	Description
DRUG	Brincidofovir
DRUG	Valganciclovir

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-05-15
• Completion: 2016-07-31
• First posted: 2015-05-12
• Last updated: 2021-07-16
• Results posted: 2021-07-16

Locations

3 sites across 1 country: United States