Trial record 1 of 1 for:    CMX001, cytomegalovirus, Phase 3
Previous Study | Return to List | Next Study

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 study is currently recruiting participants.
Verified February 2014 by Chimerix
Sponsor:
Information provided by (Responsible Party):
Chimerix
ClinicalTrials.gov Identifier:
NCT01769170
First received: January 14, 2013
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
CMV
Adenoviruses (AdV)
Epstein-Barr (EBV)
Human Herpes Virus Type 6 (HHV6)
BK Virus (BKV)
Drug: Brincidofovir (CMX001)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chimerix:

Primary Outcome Measures:
  • The primary efficacy endpoint of this study will be the incidence of clinically significant CMV infection through Week 24 posttransplant [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To describe the effect of CMX001 versus placebo on all cause mortality,non-relapse mortality and on graft failure [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    The effect of CMX001 in preventing clinical manifestations associated with non-CMV double-stranded deoxyribonucleic acid (dsDNA) viruses including BKV, HHV-6, AdV and EBV.


Estimated Enrollment: 450
Study Start Date: August 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: CMX001
placebo BIW
Drug: Brincidofovir (CMX001)
Active Comparator: CMX001 100mg
100 mg CMX001 BIW
Drug: Brincidofovir (CMX001)

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769170

Contacts
Contact: Herve Mommeja-Marin, MD 919-806-1074 clinicaltrials@chimerix.com

Locations
United States, California
University of California, San Diego-Moores Cancer Center Recruiting
LaJolla, California, United States, 92093
Principal Investigator: Randy Taplitz, MD         
United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States, 80045
Principal Investigator: Jonathan Gutman, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Kathleen Mullane, MD         
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Michael Ison, MD         
United States, Massachusetts
Beth Isreal Decaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Sub-Investigator: James Levine, MD         
Brigham and Womens Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Francisco Marty, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: George Alangaden, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Principal Investigator: Jaime Green, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Principal Investigator: Olga Derman, MD         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Principal Investigator: Genovefa Papanicolaou, MD         
Weill Cornell Medical College/NY Presbyterial Hospital Recruiting
New York, New York, United States, 10065
Principal Investigator: Tsiporah Shore, MD         
United States, North Carolina
Duke Cancer Institute Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Gwynn Long, MD         
United States, Ohio
Cincinnati Children's Hospital Recruiting
Cincinnati, Ohio, United States, 45229
Principal Investigator: Michael Grimley, MD         
United States, South Carolina
Hollings Cancer Center Recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: Saurabh Chhabra, MD         
United States, Texas
Methodist Healthcare of San Antonio Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Behyar Zoghi, MD         
United States, Utah
University of Utah, Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Principal Investigator: Michael Pulsipher, MD         
Sponsors and Collaborators
Chimerix
  More Information

No publications provided

Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT01769170     History of Changes
Other Study ID Numbers: CMX001-301
Study First Received: January 14, 2013
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Chimerix:
CMV
Hematopoietic Stem Cell Transplant Recipients
CMV seropositive

Additional relevant MeSH terms:
Adenoviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 15, 2014