A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus
NCT02439957 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2021-07-16
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.
Conditions
- Cytomegalovirus Disease
- Kidney Transplant Infection
Interventions
- DRUG
-
Brincidofovir
- DRUG
-
Valganciclovir
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-30
- Primary Completion
- 2016-05-15
- Completion
- 2016-07-31
Countries
- United States
Study Locations
More Related Trials
-
ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation
NCT01972035 ·Status: COMPLETED ·Phase: PHASE2
-
Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients
NCT06798909 ·Status: RECRUITING ·Phase: PHASE3
-
Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients
NCT00364052 ·Status: UNKNOWN
-
Study of Prophylactic Vs Preemptive Valganciclovir
NCT00374686 ·Status: COMPLETED ·Phase: NA
-
Valganciclovir to Prevent Cytomegalovirus Infection in Kidney and Kidney/Pancreas Transplant Recipients
NCT00034385 ·Status: COMPLETED ·Phase: PHASE4
-
Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients
NCT06034925 ·Status: COMPLETED ·Phase: PHASE4
-
Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)
NCT03443869 ·Status: COMPLETED ·Phase: PHASE3
-
Preventing Cytomegalovirus (CMV) Organ Damage With Valganciclovir in People With HIV
NCT00006145 ·Status: COMPLETED ·Phase: PHASE3
-
De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Transplant Recipients
NCT06001320 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients
NCT00294515 ·Status: COMPLETED ·Phase: PHASE3
-
Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation
NCT00045292 ·Status: COMPLETED ·Phase: PHASE3
-
Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients
NCT00730769 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of MCMV5322A/MCMV3068A for the Prevention of Cytomegalovirus Disease in High-Risk Kidney Allograft Recipients
NCT01753167 ·Status: COMPLETED ·Phase: PHASE2
-
CMX001 in Post-transplant Patients With BK Virus Viruria
NCT00793598 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients
NCT00497796 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus Infection
NCT02087306 ·Status: COMPLETED ·Phase: PHASE3
-
A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection
NCT04225923 ·Status: COMPLETED ·Phase: PHASE2
-
Quantiferon - Cytomegalovirus (CMV) and the Prediction of CMV Infection In High Risk Solid Organ Transplant Recipients
NCT00817908 ·Status: COMPLETED
-
Treating Kidney Donors With Valganciclovir to Reduce Viral Transmission to Recipients
NCT01329185 ·Status: COMPLETED ·Phase: PHASE2
-
TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant
NCT00386412 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation
NCT00372229 ·Status: COMPLETED ·Phase: PHASE3
-
A Multicenter Study to Obtain Retrospective Data for Subjects Previously Diagnosed With Adenovirus Infection to Serve as Matched Historical Controls for Study CMX001-304
NCT02420080 ·Status: TERMINATED
-
Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation
NCT00016068 ·Status: COMPLETED ·Phase: PHASE3
-
Randomized Clinical Trial, Open, Multicenter Parallel, no Suspension Inferiority Prophylactic Treatment With Valganciclovir in Kidney Transplant CMV-seropositive Cellular Immunity to Develop CD8 + CMV-specific Treatment After Induction Thymoglobulin.
NCT03123627 ·Status: COMPLETED ·Phase: PHASE3
-
Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients
NCT01611974 ·Status: COMPLETED ·Phase: PHASE2