A Study of the Safety and Efficacy of CMX001 for the Prevention of Cytomegalovirus (CMV) Infection in CMV-seropositive (R+) Hematopoietic Stem Cell Transplant Recipients
This trial has been completed.
|Conditions||cmv, adenoviruses (adv), epstein-barr (ebv), human herpes virus type 6 (hhv6), bk virus (bkv)|
|Start date||August 2013|
|End date||December 2015|
|Trial size||458 participants|
|Trial identifier||NCT01769170, CMX001-301|
The purpose of this study is to compare the effectiveness of CMX001 to placebo for the prevention of CMV infection in stem cell transplant patient who do not have CMV before starting treatment with CMX001.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
100 mg CMX001 BIW
The primary efficacy endpoint of this study will be the incidence of clinically significant CMV infection through Week 24 posttransplant
time frame: 24 weeks
To describe the effect of CMX001 versus placebo on all cause mortality,non-relapse mortality and on graft failure
time frame: 24 Weeks
Male or female participants from 18 years up to 89 years old.
Inclusion Criteria: - Subjects will be adult allogeneic HSCT recipients aged ≥ 18 years-old (or as applicable, per local law) who were CMV seropositive before transplantation and are CMV viremia negative posttransplant. Exclusion Criteria: - Subjects who have a positive CMV viremia test at any time between transplant and the First Dose Day (FDD). - Subjects with hypersensitivity (not renal dysfunction or eye disorder) to CDV or to CMX001 or its excipients. - Subjects who have received any anti-CMV therapy and investigational anti-CMV drugs at any time posttransplant. - Subjects who have had any anti-CMV vaccine at any time.
|Official title||A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study of the Safety, Tolerability, and Efficacy of CMX001 for the Prevention of Cytomegalovirus (CMV) Infection in CMV-seropositive (R+) Hematopoietic Stem Cell Transplant Recipients|
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