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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01769170
First Posted: January 16, 2013
Last Update Posted: November 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chimerix
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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 ]
    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.


Enrollment: 458
Study Start Date: August 2013
Study Completion Date: January 2016
Primary Completion Date: December 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769170


  Show 43 Study Locations
Sponsors and Collaborators
Chimerix
  More Information

Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT01769170     History of Changes
Other Study ID Numbers: CMX001-301
First Submitted: January 14, 2013
First Posted: January 16, 2013
Last Update Posted: November 11, 2016
Last Verified: November 2016

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


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