This trial is active, not recruiting.

Conditions cmv, adenoviruses (adv), epstein-barr (ebv), human herpes virus type 6 (hhv6), bk virus (bkv)
Treatment brincidofovir (cmx001)
Phase phase 3
Sponsor Chimerix
Start date August 2013
End date September 2015
Trial size 450 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

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
placebo BIW
brincidofovir (cmx001)
(Active Comparator)
100 mg CMX001 BIW
brincidofovir (cmx001)

Primary Outcomes

The primary efficacy endpoint of this study will be the incidence of clinically significant CMV infection through Week 24 posttransplant
time frame: 24 weeks

Secondary Outcomes

To describe the effect of CMX001 versus placebo on all cause mortality,non-relapse mortality and on graft failure
time frame: 24 Weeks

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Chimerix.
Location data was received from the National Cancer Institute and was last updated in June 2016.