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Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease

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.
 
ClinicalTrials.gov Identifier: NCT02596997
Expanded Access Status : No longer available
First Posted : November 4, 2015
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Chimerix

Brief Summary:
Provide patients with serious AdV infection or disease access to treatment with BCV.

Condition or disease Intervention/treatment
Adenovirus Drug: Brincidofovir

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Study Type : Expanded Access
Official Title: An Intermediate-size, Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Brincidofovir
    Up to 100mg Brincidofovir twice weekly, not to exceed a total dose of 200mg each week
    Other Name: BCV CMX001

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Confirmed serious AdV infection based on clinical symptoms and laboratory testing showing AdV in the blood or other bodily fluids
  • Able to swallow medication, either tablet or liquid

Exclusion Criteria:

  • Previous dosing with Brincidofovir
  • If female, not pregnant or trying to become pregnant

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): NCT02596997


Locations
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United States, Arkansas
University of Arkansas Medical Center
Little Rock, Arkansas, United States, 72205
United States, California
Children's Hospital LA
Los Angeles, California, United States, 90027
UCLA Medical Center
Los Angeles, California, United States, 90095
Children's Hospital of Orange County
Orange, California, United States, 92868
Pediatric Stem Cell Transplantation Stanford University
Palo Alto, California, United States, 94304
Stanford University
Palo Alto, California, United States, 94304
UC San Diego Moores Cancer center
San Diego, California, United States, 92037
University of California San Francisco Benioff Children's Hospital
San Francisco, California, United States, 94143
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
All Childrens Research Institute
Saint Petersburg, Florida, United States, 33606
All Children's Research Institute
Saint Petersburg, Florida, United States, 33701
United States, Georgia
Emory University-AFLAC Cancer and Blood Disorder Clinic
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, Kansas
Children's Mercy Hospital
Kansas City, Kansas, United States, 64108
United States, Kentucky
University of Louisville-Kosair Childrens Hospital
Louisville, Kentucky, United States, 40292
United States, Louisiana
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
United States, Massachusetts
Brigham & Woman's Hospital/Boston
Boston, Massachusetts, United States, 02115
United States, Michigan
Michigan State/Spectrum Health
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63130
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68198-5400
United States, New Jersey
Hackensack University MC
Hackensack, New Jersey, United States, 07601
United States, New York
The Children's Hospital at Montefiore
Bronx, New York, United States, 10467
Weill Conrell Medical Center
New York, New York, United States, 10021
Morgan Stanley Children's Hospital
New York, New York, United States, 10032
Memorial Sloan Kettering
New York, New York, United States, 10065
New York Medical College-Maria Fareri Childrens hospital
New York, New York, United States, 10595
New York Medical College, Maria Fareri Children's Hospital
Valhalla, New York, United States, 10595
United States, North Carolina
Levine Children's Hospital
Charlotte, North Carolina, United States, 28203
Duke University Medical System
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnatti Children's Hospital
Cincinnati, Ohio, United States, 45229
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
The Childrens hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Methodist University Hospital-BMT program west clinic
Memphis, Tennessee, United States, 38104
St. Jude Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75235
Cook Children's Health Care System
Fort Worth, Texas, United States, 76104
Baylor College of Medicine-Infectious Disease
Houston, Texas, United States, 77030
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229
United States, Washington
University of Washington/ Seattle Children's Hospital
Seattle, Washington, United States, 98105
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98195
United States, Wisconsin
Medical College of Wisconsin
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
Chimerix
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Responsible Party: Chimerix
ClinicalTrials.gov Identifier: NCT02596997    
Other Study ID Numbers: CMX001-351
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: February 2020
Keywords provided by Chimerix:
Adenovirus Brincidofovir
Additional relevant MeSH terms:
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Adenoviridae Infections
DNA Virus Infections
Virus Diseases