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

Phase 3
Terminated
Conditions
Cytomegalovirus Disease
Interventions
Registration Number
NCT02439970
Lead Sponsor
Chimerix
Brief 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

Detailed 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).

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
5
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Treatment 1Brincidofovir100 mg brincidofovir (BCV; 1 tablet) administered orally twice weekly, plus valganciclovir (vGCV) placebo (2 tablets) administered orally once daily.
Treatment 2Valganciclovir900 mg valganciclovir (vGCV; two 450 mg tablets) administered orally once daily, plus brincidofovir (BCV) placebo (1 tablet) administered orally twice weekly.
Primary Outcome Measures
NameTimeMethod
The Incidence of CMV Disease52 weeks (± 28 days)

The incidence of CMV disease included CMV tissue-invasive disease and CMV syndrome, occurring anytime between randomization and Week 52 (± 28 days).

The proportion of subjects that 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). 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

St. Vincent Medical Center

🇺🇸

Los Angeles, California, United States

University of Colorado Hospital/Health Science Center

🇺🇸

Aurora, Colorado, United States

Yale New Haven Hospital

🇺🇸

New Haven, Connecticut, United States

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