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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

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ClinicalTrials.gov Identifier: NCT01769170
Recruitment Status : Completed
First Posted : January 16, 2013
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
CMV Adenoviruses (AdV) Epstein-Barr (EBV) Human Herpes Virus Type 6 (HHV6) BK Virus (BKV) Drug: Brincidofovir (CMX001) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 458 participants
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
Study Start Date : August 2013
Primary Completion Date : December 2015
Study Completion Date : January 2016
Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: CMX001
placebo BIW
Drug: Brincidofovir (CMX001)
Active Comparator: CMX001 100mg
100 mg CMX001 BIW
Drug: Brincidofovir (CMX001)


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: January 16, 2013    Key Record Dates
Last Update Posted: November 11, 2016
Last Verified: November 2016

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