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

Phase 3

Terminated

• Conditions: Cytomegalovirus Disease; Kidney Transplant Infection
• Interventions: Drug: Valganciclovir; Drug: Brincidofovir

• Registration Number: NCT02439957
• Lead Sponsor: Chimerix

Brief 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).

Study Timeline

• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Study Start: 2015-09
• Primary Completion: 2016-05-15
• Study Completion: 2016-07-31
• Status Verified: 2021-06
• Results First Submitted: 2021-06-27
• Results First Submitted QC: 2021-06-27
• Last Update Submitted: 2021-06-27
• Results First Posted: 2021-07-16
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment 2	Valganciclovir	900 mg valanciclovir (vGCV; two 450 tablets) once daily plus brincidofovir (BCV) placebo (1 tablet) twice weekly.
Treatment 1	Brincidofovir	100 mg brincidofovir (BCV; one 100 mg tablet) twice weekly plus valganciclovir (vGCV) placebo (2 tablets) once daily.

Primary Outcome Measures

Name	Time	Method
The Incidence of Cytomegalovirus (CMV) Disease	24 weeks (±14 days)	The incidence of CMV disease, which included CMV tissue-invasive disease and CMV syndrome, occurring anytime between randomization and Week 24 posttransplant (±14 days).; The proportion of subjects who met this failure endpoint were to be compared between brincidofovir (BCV) and valganciclovir (vGCV) using an unadjusted 95% confidence interval (CI) of the absolute difference between groups (BCV minus vGCV). Number of failures and failure rates were to be presented for each treatment. If the upper bound of the 95% CI fell below 10%, BCV would have demonstrated non-inferiority to vGCV. In the event that the upper bound of the 95% CI fell below 0%, BCV would have additionally demonstrated superiority over vGCV.

Trial Locations

Locations (3)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

University of Colorado Hospital/Health Science Center; 🇺🇸 Aurora, Colorado, United States

St. Vincent Medical Center; 🇺🇸 Los Angeles, California, United States