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. (see Contacts and Locations)
Verified May 2014 by Chimerix
Sponsor:
Information provided by (Responsible Party):
Chimerix
ClinicalTrials.gov Identifier:
NCT01769170
First received: January 14, 2013
Last updated: May 16, 2014
Last verified: May 2014

January 14, 2013
May 16, 2014
August 2013
May 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01769170 on ClinicalTrials.gov Archive Site
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.
To describe the effect of CMX001 versus placebo on overall and non-relapse mortality and on graft failure [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • CMV
  • Adenoviruses (AdV)
  • Epstein-Barr (EBV)
  • Human Herpes Virus Type 6 (HHV6)
  • BK Virus (BKV)
Drug: Brincidofovir (CMX001)
  • Placebo Comparator: CMX001
    placebo BIW
    Intervention: Drug: Brincidofovir (CMX001)
  • Active Comparator: CMX001 100mg
    100 mg CMX001 BIW
    Intervention: Drug: Brincidofovir (CMX001)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
September 2015
May 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 89 Years
No
Contact: Herve Mommeja-Marin, MD 919-806-1074 clinicaltrials@chimerix.com
United States
 
NCT01769170
CMX001-301
Not Provided
Chimerix
Chimerix
Not Provided
Not Provided
Chimerix
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP