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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

  Show 31 Study Locations
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: May 16, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014