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Trial record 1 of 8 for:    brincidofovir adenovirus
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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)

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ClinicalTrials.gov Identifier: NCT02087306
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Chimerix

Brief Summary:
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 or disease Intervention/treatment Phase
Adenovirus Infection Drug: CMX001 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
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)
Study Start Date : March 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: CMX001 Drug: CMX001
CMX001 administered twice weekly, dose depending on weight.
Other Name: Brincidofovir




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 75 Years   (Child, Adult, Older Adult)
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.

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


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Locations
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United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Stanford Children's Hospital
Palo Alto, California, United States, 94305
Stanford University
Stanford, California, United States, 94305
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, District of Columbia
Children's National Health System
Washington, District of Columbia, United States, 20010
United States, Georgia
Children's Healthcare of Atlanta, Aflac Cancer and Blood Center
Atlanta, Georgia, United States, 30322
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
United States, Louisiana
Children's Hospital
New Orleans, Louisiana, United States, 70118
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Brigham and Woman's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68198
United States, New York
Montifore Medical Center
Bronx, New York, United States, 10467
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Weill Cornell Medical College/ New York Presbyterian Hospital
New York, New York, United States, 10065
United States, North Carolina
Levine Children's Hospital
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 27712
United States, Ohio
Cincinnatti Children's Hospital
Cincinnatti, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
St. Jude Children's Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Baylor College of Medicine
Houston, Texas, United States, 77030
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Intermountain Healthcare Research
Salt Lake City, Utah, United States, 84103
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Washington
Fred Hutchingson Cancer Center
Seattle, Washington, United States, 19024
Seattle Children's Hospital
Seattle, Washington, United States, 98105
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Chimerix

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

Keywords provided by Chimerix:
Adenovirus Infection

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