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Phase III, Open-labeled, Multicenter Study of the Safety and Efficacy of Brincidofovir (CMX001) in the Treatment of Early Versus Late Adenovirus Infection (CMX001 Adv)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02087306
First Posted: March 14, 2014
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
This is a multicenter study of Brincidofovir (CMX001) (BCV) administered twice weekly (BIW) for the treatment of AdV infection detected during asymptomatic AdV viremia or during symptomatic AdV infection. After completing a screening assessment to confirm study eligibility, all enrolled subjects will undergo a treatment period of 12 weeks. Beginning on Day 1, adult (≥ 18 years) and adolescent (13-17 years) subjects weighing > 50 kg will receive BCV 100 mg BIW; children up to 12 years of age will receive weight-based doses of 2 mg/kg BIW, not-to-exceed a total dose of 200 mg/week.

Condition Intervention Phase
Adenovirus Infection Drug: CMX001 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, Multicenter Study of the Safety and Efficacy of Brincidofovir (CMX001) in the Treatment of Early Versus Late Adenovirus Infection (Chimerix Study CMX001-304)

Further study details as provided by Chimerix:

Primary Outcome Measures:
  • To compare the overall mortality at Week 24 of subjects treated with BCV during asymptomatic adenovirus (AdV) viremia or "early" AdV infection to the mortality at Week 24 for subjects treated with BCV during symptomatic or "late" AdV disease [ Time Frame: 24 weeks ]
    To compare the overall mortality at Week 24 of subjects treated with BCV during asymptomatic adenovirus (AdV) viremia or "early" AdV infection to the mortality at Week 24 for subjects treated with BCV during symptomatic or "late" AdV disease


Enrollment: 201
Study Start Date: March 2014
Study Completion Date: August 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CMX001 Drug: CMX001
CMX001 administered twice weekly, dose depending on weight.
Other Name: Brincidofovir

  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:   2 Months to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have undergone hematopoietic cell transplant (HCT), solid organ transplant (SOT)
  • Have a primary or other severe immunodeficiency which predisposes to rapid progression to disseminated AdV disease
  • Must be able to ingest, absorb and tolerate oral medication
  • Willing and able to understand and provide written informed consent. For minors or those incapable of providing written informed consent (i.e., incapacitated), understood, written and informed consent must be provided by a parent or legal guardian or representative.
  • To the best of his or her (or parent/guardian) knowledge, willing and able to participate in all required study activities for the duration of the study.

Exclusion Criteria:

  • Females who are pregnant or currently nursing.
  • Patients with any other condition that would, in the judgment of the investigator, put the patient at increased risk during participation in the study, or interfere with the conduct of the study.
  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): NCT02087306


  Show 34 Study Locations
Sponsors and Collaborators
Chimerix
  More Information

Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT02087306     History of Changes
Other Study ID Numbers: CMX001 304
First Submitted: March 12, 2014
First Posted: March 14, 2014
Last Update Posted: November 11, 2016
Last Verified: August 2015

Keywords provided by Chimerix:
Adenovirus Infection

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


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