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

March 10, 2022 updated by: Chimerix

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

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

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas Medical Center
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Los Angeles, California, United States, 90027
        • Children's Hospital LA
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • Palo Alto, California, United States, 94304
        • Stanford University
      • Palo Alto, California, United States, 94304
        • Pediatric Stem Cell Transplantation Stanford University
      • San Diego, California, United States, 92037
        • UC San Diego Moores Cancer Center
      • San Francisco, California, United States, 94143
        • University of California San Francisco Benioff Children's Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Saint Petersburg, Florida, United States, 33701
        • All Children's Research Institute
      • Saint Petersburg, Florida, United States, 33606
        • All Childrens Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University-AFLAC Cancer and Blood Disorder Clinic
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Kansas
      • Kansas City, Kansas, United States, 64108
        • Children's Mercy Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40292
        • University of Louisville-Kosair Childrens Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Children's Hospital New Orleans
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Woman's Hospital/Boston
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Michigan State/Spectrum Health
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68198-5400
        • University of Nebraska
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University MC
    • New York
      • Bronx, New York, United States, 10467
        • The Children's Hospital at Montefiore
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering
      • New York, New York, United States, 10021
        • Weill Conrell Medical Center
      • New York, New York, United States, 10032
        • Morgan Stanley Children's Hospital
      • New York, New York, United States, 10595
        • New York Medical College-Maria Fareri Childrens hospital
      • Valhalla, New York, United States, 10595
        • New York Medical College, Maria Fareri Children's Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Levine Children's Hospital
      • Durham, North Carolina, United States, 27710
        • Duke University Medical System
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnatti Children's Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Childrens Hospital of Philadelphia
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist University Hospital-BMT program west clinic
      • Memphis, Tennessee, United States, 38105
        • St. Jude Research Hospital
    • Texas
      • Dallas, Texas, United States, 75235
        • UT Southwestern Medical Center
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Health Care System
      • Houston, Texas, United States, 77030
        • University of Texas, MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine-Infectious Disease
      • San Antonio, Texas, United States, 78229
        • Methodist Children's Hospital of South Texas
    • Washington
      • Seattle, Washington, United States, 98195
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, United States, 98105
        • University of Washington/ Seattle Children's Hospital
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chimerix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimate)

November 4, 2015

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMX001-351

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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