Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-08 @ 9:28 AM
Study NCT ID:
NCT02439957
Status:
TERMINATED
Last Update Posted:
2021-07-16
First Post:
2015-05-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus
Sponsor:
Jazz Pharmaceuticals
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated early due to results from another CMX001 study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: