Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients
- Registration Number
- NCT00942305
- Lead Sponsor
- Chimerix
- Brief Summary
This was a multicenter, randomized, double-blind, placebo-controlled, dose-escalation study of brincidofovir (BCV) administered orally once or twice weekly for up to 11 weeks. Dosing was initiated immediately following engraftment (between Days 14-30 post-transplant) to prevent/control cytomegalovirus (CMV) infection or prevent disease in R+ hematopoietic stem cell transplant (HCT) recipients.
- Detailed Description
This was to be a 2-part study. Part 1 was a randomized, double-blind, placebo-controlled, dose-escalation study of multiple doses of oral brincidofovir (BCV) in R+ hematopoietic stem cell transplant (HCT) recipients. In Part 2, one of the dose levels administered in Part 1 was to be tested against placebo to evaluate the statistical significance of BCV as a therapy for preventing progression of cytomegalovirus (CMV) infection or preventing CMV disease. The first 3 dose-escalating cohorts in Part 1 were to include 32 subjects within each cohort (24 randomized to receive oral BCV and 8 randomized to receive placebo in a 3:1 ratio) for a total of 96 planned subjects. Following completion of the first 3 cohorts and subsequent safety review of the data, up to an additional 3 cohorts of 32 subjects each could have been enrolled. Two additional cohorts (labeled Cohort 4 and Cohort 4A) beyond the initial 3 cohorts were actually enrolled in Part 1 of the study. Following the safety and antiviral activity analyses of the 5 cohorts in Part 1 and the number of subjects enrolled in each of those cohorts, Part 2 of the study was not conducted.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 239
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo Placebo * Cohort 1 = 40 mg of matching placebo administered once weekly (QW) * Cohort 2 = 100 mg of matching placebo administered QW * Cohort 3 = 200 mg of matching placebo administered QW * Cohort 4 = 200 mg of matching placebo administered twice weekly (BIW) * Cohort 4A = 100 mg of matching placebo administered BIW Brincidofovir Brincidofovir * Cohort 1 = 40 mg brincidofovir (BCV) administered once weekly (QW) * Cohort 2 = 100 mg BCV administered QW * Cohort 3 = 200 mg BCV administered QW * Cohort 4 = 200 mg BCV administered twice weekly (BIW) * Cohort 4A = 100 mg BCV administered BIW
- Primary Outcome Measures
Name Time Method Number of Participants With Clinically Significant CMV Infection Randomization to Week 8 post-treatment (~19 weeks) The primary efficacy endpoint was a binomial outcome of failure to prevent cytomegalovirus (CMV) infection defined as CMV DNAemia \>200 copies/mL obtained at the time of the last treatment with study drug or diagnosis of CMV disease at some point during the treatment phase.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Winship Cancer Institute at Emory University
🇺🇸Atlanta, Georgia, United States
UT Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Brigham and Womens Hospital, Division of Infectious Disease
🇺🇸Boston, Massachusetts, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
The Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Utah Cancer Specialists - Intermountain Healthcare
🇺🇸Salt Lake City, Utah, United States
University of Texas, MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Harper University Hospital
🇺🇸Detroit, Michigan, United States
Mt. Sinai School of Medicine
🇺🇸New York, New York, United States
Montefiore Medical Center Oncology
🇺🇸Bronx, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
University of Michigan Medical School
🇺🇸Ann Arbor, Michigan, United States
Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
UNC Health Care Center
🇺🇸Chapel Hill, North Carolina, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States