A Study of the Safety and Efficacy of CMX001 for the Prevention of CMV Infection in CMV-seropositive HCT Recipients
- Registration Number
- NCT01769170
- Lead Sponsor
- Chimerix
- Brief Summary
This randomized, double-blind, placebo-controlled, parallel group, multicenter study compared the effectiveness of oral brincidofovir (BCV) to placebo for the prevention of cytomegalovirus (CMV) infection in stem cell transplant patients who were CMV seropositive but negative for CMV viremia before starting treatment with BCV.
- Detailed Description
This was a randomized, double-blind, placebo-controlled, parallel group multicenter study of oral brincidofovir (BCV) in approximately 450 cytomegalovirus (CMV)-seropositive subjects who had undergone allogeneic hematopoietic stem cell transplantation (HCT). The study consisted of a screening evaluation and a treatment phase of 10 to 14 weeks. Dosing with the study drug (BCV or placebo) was initiated as soon as individual subjects could ingest tablets after transplant but no later than Day 28 post-transplant, and was continued through Week 14. All randomized subjects remained on study and followed the same scheduled study treatment. Study assessments were performed weekly from randomization through completion of the first post-treatment follow-up assessment at Week 15, and every 3 weeks thereafter through Week 24.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 452
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Matching placebo administered orally twice weekly Brincidofovir Brincidofovir 100 mg brincidofovir administered orally twice weekly
- Primary Outcome Measures
Name Time Method Number of Participants With Clinically Significant CMV Infection Through Week 24 Post-Transplant 24 weeks Clinically significant cytomegalovirus (CMV) infection was defined by either of the following outcomes:
1. Onset of CMV end-organ disease; or
2. Initiation of anti-CMV-specific preemptive therapy based on documented CMV viremia (as measured by the central virology laboratory) and the clinical condition of the subject.
CMV viremia (i.e., the measurement of CMV DNA in plasma) was determined by the designated central virology laboratory at all scheduled visits via quantitative polymerase chain reaction (qPCR) testing using the Roche COBAS® AmpliPrep/COBAS® TaqMan® CMV Test.
- Secondary Outcome Measures
Name Time Method Incidence of Clinically Significant CMV Infection Through Week 14 14 weeks The incidence of clinically significant cytomegalovirus (CMV) infection through Week 14.
Blood and urine for virologic evaluations were collected at screening, pre-dose on the first day of study drug administration, and at pre-specified intervals throughout the treatment phases of the study and sent to a designated central virology laboratory for analysis. Blood samples were used for real-time assay of CMV viremia in plasma using a qPCR assay. Urine samples were stored for possible future retrospective analyses of CMV.
Trial Locations
- Locations (43)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
The Universit of Iowa
🇺🇸Iowa City, Iowa, United States
University of California, San Diego-Moores Cancer Center
🇺🇸La Jolla, California, United States
Mt. Sinai Medical Center
🇺🇸New York, New York, United States
Winship Cancer Institute-Emory
🇺🇸Atlanta, Georgia, United States
Hackensack University
🇺🇸Hackensack, New Jersey, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Weill Cornell Medical College/NY Presbyterial Hospital
🇺🇸New York, New York, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
Levine Cancer Institute/Carolinas Health
🇺🇸Charlotte, North Carolina, United States
Wake Forest
🇺🇸Winston-Salem, North Carolina, United States
University of Toronto
🇨🇦Toronto, Ontario, Canada
Allegheny-Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Cliniques Universitaires Saint Luc
🇧🇪Brussels, Belgium
Brigham and Womens Hospital
🇺🇸Boston, Massachusetts, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Beth Isreal Decaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
University of Miami Hospital
🇺🇸Miami, Florida, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
The Jewish Hospital
🇺🇸Cincinnati, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Methodist Healthcare of San Antonio
🇺🇸San Antonio, Texas, United States
University of Utah, Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Intermountain Healthcare
🇺🇸Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Centre Hospitalier Universitaire Sart Tilman Liege
🇧🇪Brüssel, Liege, Belgium
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
University of Colorado
🇺🇸Denver, Colorado, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
Centre Hospitalier Universitaire de Montreal, Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Harper University Hospital
🇺🇸Detroit, Michigan, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States