A Study of the Safety and Efficacy of CMX001 for the Prevention of CMV Infection in CMV-seropositive HCT Recipients
A 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
1 other identifier
interventional
452
3 countries
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2013
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2013
CompletedFirst Posted
Study publicly available on registry
January 16, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
January 5, 2021
CompletedJuly 21, 2021
July 1, 2021
2.3 years
January 14, 2013
December 9, 2020
July 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Clinically Significant CMV Infection Through Week 24 Post-Transplant
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.
24 weeks
Secondary Outcomes (1)
Incidence of Clinically Significant CMV Infection Through Week 14
14 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORMatching placebo administered orally twice weekly
Brincidofovir
ACTIVE COMPARATOR100 mg brincidofovir administered orally twice weekly
Interventions
Eligibility Criteria
You may qualify if:
- Subjects were required to meet all of the following criteria, as applicable, to be eligible to participate in this study:
- Were allogeneic hematopoietic stem cell transplant (HCT) recipients who had prior evidence of cytomegalovirus (CMV) exposure (CMV-seropositive) before transplantation and were CMV viremia negative at screening and at any other assessments performed prior to the first dose of study drug.
- Were aged ≥18 years.
- If male, were willing to use an acceptable contraceptive method(s) throughout the duration of his participation in the study, i.e., through Week 24, when engaging in sexual intercourse with a female subject of childbearing potential.
- If female of childbearing potential, i.e., not postmenopausal or surgically sterile, were willing to use 2 acceptable contraceptive methods, 1 of which must have been a barrier method, throughout the duration of her participation in the study, i.e., through Week 24, when engaging in sexual intercourse with a nonsterile male partner.
- Were able to begin study drug dosing within 28 days following the qualifying HCT.
- Were able to comfortably ingest and absorb oral medication (in the judgment of the investigator and base don lack of significant gastrointestinal events/medical history).
- Were willing and able to understand and provide written informed consent.
- Were willing and able to participate in all required study activities for the entire duration of the study (i.e., through Week 24).
You may not qualify if:
- Subjects who met any of the following criteria, as applicable, were not eligible to participate in this study:
- Was pregnant or planned to become pregnant during the anticipated duration of her participation in the study (i.e., through Week 24), or was nursing a child.
- Had a positive CMV viremia test (at the designated central virology laboratory or a local virology laboratory) at any time between transplant and the first dose of study drug.
- Weighed ≥120 kg (\~265 lbs).
- Had hypersensitivity (not renal dysfunction or eye disorder) to cidofovir (CDV), brincidofovir (BCV), or its excipients.
- Had received (or were anticipated to need treatment with) any of the following:
- Ganciclovir, valganciclovir, foscarnet, intravenous CDV, or any other anti-CMV therapy (including CMV immune globulin, cell-based therapies, and investigational anti-CMV drugs, e.g., leflunomide, letermovir, or maribavir) at any time post-transplant;
- Any anti-CMV vaccine at any time;
- Any other investigation drug within 14 days prior to the first dose of study drug (unless prior approval had been received from the Chimerix medical monitor or designee); or
- Prior treatment with BCV at any time.
- Were receiving of the following drugs on the first dose of study drug or were anticipated to receive any of these drugs at the doses described after the first dose of study drug:
- Acyclovir orally at \>2000 mg total daily dose (TDD) or intravenously at \>15 mg/kg TDD;
- Valaciclovir at \>3000 mg TDD; or
- Leflunomide at any dose.
- Were receiving digoxin or ketoconazole (other than topical formulations) at the first dose of study drug or were anticipated to need treatment with either digoxin or ketoconazole during the treatment phase (through Week 14).
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
University of California, San Diego-Moores Cancer Center
La Jolla, California, 92093, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
University of Colorado
Denver, Colorado, 80045, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
University of Miami Hospital
Miami, Florida, 33136, United States
Winship Cancer Institute-Emory
Atlanta, Georgia, 30322, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
The Universit of Iowa
Iowa City, Iowa, 45229, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Beth Isreal Decaconess Medical Center
Boston, Massachusetts, 02115, United States
Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Harper University Hospital
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Hackensack University
Hackensack, New Jersey, 07601, United States
Mt. Sinai Medical Center
New York, New York, 10029, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Weill Cornell Medical College/NY Presbyterial Hospital
New York, New York, 10065, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Levine Cancer Institute/Carolinas Health
Charlotte, North Carolina, 28204, United States
Duke Cancer Institute
Durham, North Carolina, 27710, United States
Wake Forest
Winston-Salem, North Carolina, 27517, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
The Jewish Hospital
Cincinnati, Ohio, 45236, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15224, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Methodist Healthcare of San Antonio
San Antonio, Texas, 78229, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Intermountain Healthcare
Salt Lake City, Utah, 84143, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Centre Hospitalier Universitaire Sart Tilman Liege
Brussels, Liege, 4000, Belgium
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
University of Toronto
Toronto, Ontario, M5G2C4, Canada
Centre Hospitalier Universitaire de Montreal, Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Related Publications (1)
Marty FM, Winston DJ, Chemaly RF, Mullane KM, Shore TB, Papanicolaou GA, Chittick G, Brundage TM, Wilson C, Morrison ME, Foster SA, Nichols WG, Boeckh MJ; SUPPRESS Trial Clinical Study Group. A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Oral Brincidofovir for Cytomegalovirus Prophylaxis in Allogeneic Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2019 Feb;25(2):369-381. doi: 10.1016/j.bbmt.2018.09.038. Epub 2018 Oct 4.
PMID: 30292744RESULT
MeSH Terms
Interventions
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Chimerix, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2013
First Posted
January 16, 2013
Study Start
August 1, 2013
Primary Completion
December 1, 2015
Study Completion
January 1, 2016
Last Updated
July 21, 2021
Results First Posted
January 5, 2021
Record last verified: 2021-07